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Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01531153
Enrollment
93
Registered
2012-02-10
Start date
2011-09-30
Completion date
2016-06-30
Last updated
2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction

Keywords

Cocaine use decreases, increases or stays the same

Brief summary

Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in reducing cocaine use as measured by cocaine urine results and self-report days of use. Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention during the first four weeks of treatment will mediate galantamine's efficacy in reducing cocaine use.

Detailed description

This will be a double-blind, placebo-controlled, randomized clinical trial. One hundred and twenty cocaine-dependent men and women will be randomized to one of three treatment groups: placebo (n=40), 8 mg/day (n=40), and 16 mg/day (n=40) of extended release (ER) galantamine. An urn randomization will be used to balance the groups for gender, severity of cocaine use (measured by days of cocaine use), baseline cognitive functioning \[determined via the Shipley Institute of Living Scale (SILS)\], and smoking status. Gender and severity of cocaine use have been shown to predict treatment responses in cocaine users (76). Similarly, balancing the treatment groups for baseline cognitive functioning, assessed with the SILS scores, will minimize the influence of baseline differences on cognitive outcomes (77, 78). Smoking status is also an important baseline variable, given galantamine's actions on nicotinic receptors and its potential efficacy for smoking cessation (65). The initial dose of galantamine will be 8 mg/day as a single dose, as recommended for clinical use. For those assigned to 16 mg/day, the dose of galantamine will be increased to 16 mg at the end of week 4. Treatment groups will remain on their full dosage through week 13. All participants will receive contingency management (CM) targeting treatment compliance. In three previous cocaine pharmacotherapy trials using bupropion, desipramine or levodopa, medication efficacy on cocaine use was evident only when medications were combined with CM, but not with standard care (79-81). These findings provide a strong rationale for using CM in our clinical trial. Recruitment is continuing. This protocol was amended as of May 2014 to come to one dispensing visit and up too, two clinic visits. The payment has changed from gift cards to cash. This change should help increase the number of completers. Currently there are 40 completers with 9 active and 6 in follow up phase. The follow up phase ended June 2016. Currently in analysis.

Interventions

DRUGGalantamine

8mg or 16mg

DRUGPlacebo

Placebo dose.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Male and females, between the ages of 18 and 60 2. Are using cocaine more than once per week in the previous 30 days, provide a cocaine-positive urine specimen at screening, and fulfill criteria for current cocaine dependence according to DSM-IV 3. For women of child-bearing age, have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly pregnancy tests 4. Are fluent in English and have a 6th grade or higher reading level; AND 5. Can commit to at least 13 weeks of treatment and are willing to be randomized to treatment

Exclusion criteria

1. Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued 2. Current DSM-IV diagnosis of drug or alcohol dependence (other than cocaine, or tobacco) 3. Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal deficit and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment 4. Use of other medications including: * drugs that slow heart rate (e.g., beta-blockers), which may increase the risk of bradycardia and atrioventricular (AV) block and * non-steroidal anti-inflammatory drugs (NSAIDs); increased potential for developing ulcers/active or occult gastrointestinal bleeding 5. Have a screening liver function test (AST or ALT) greater than 3 times normal; OR 6. Known allergy or adverse reaction to galantamine

Design outcomes

Primary

MeasureTime frameDescription
Urine Toxicology12 weeksPresented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.

Secondary

MeasureTime frameDescription
Blood Pressure- Systolic2 times a week for 12 weeksBlood Pressure is taken for safety reasons
Blood Pressure- Diastolic2 times a week for 12 weeksBlood Pressure is taken for safety reasons
CANTAB RVIP Measure: RVP ABaseline and 12 WeeksRVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP A' (aka RVIP A PRIME): is a signal detection measure of target sensitivity (i.e., successful response to targets and withholding of responses to non-targets). Range of 0 to 1. Higher scores are better.
CANTAB RVIP Measure: RVP BBaseline and 12 WeeksRVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP B: A measure of response bias (i.e., bias towards under-responding (to targets) versus over-responding (i.e., to non-targets)) range from -1 to +1, respectively.
CANTAB RVIP Measure: RVP FALSE ALARMBaseline and 12 WeeksRVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP FALSE ALARM is probability of false alarm. False alarms are responses to non-targets. Higher numbers are worse (i.e., could be seen as a measure of poor response inhibition). Scores range from 0-1 where 1 is the least desirable probablity.
CANTAB SST- SSRTBaseline and 12 WeeksThis is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'.
CANTAB SST- Median CorrectBaseline and 12 WeeksThis is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. Median correct is the median of response times across 'go' trials where the subject has responded on the correct button (right or left).
Heart Rateonce a day for up to two days over 12 WeeksPulse
Stroop- RT Correct Neutralweeks 0, 4, 8, 12, 16, 24, 36Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Neutral is the mean response time to neutral trials where the subject pressed the correct color response.
Stroop- RT Correct Drugweeks 0, 4, 8, 12, 16, 24, 36Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Drug is the mean response time to drug trials where the subject pressed the correct color response.
Stroop- Effect Drug Neutral Mean Correctweeks 0, 4, 8, 12, 16, 24, 36Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. Stroop Effect is difference in response time to drug versus neutral trials (i.e., RT Correct Drug - RT Correct Neutral). A larger stroop effect is 'worse' (thought to indicate more attentional bias to drug related stimuli).
Digit Span- LDSFBaseline and 12 WeeksDigit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Forward (LDSF) is the longest digit span a participant gets correct, in the forward condition. Higher scores are better (Scale of 0 to 9).
Digit Span- DSFBaseline and 12 WeeksDigit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSF) is the number of digit span trials participants got correct in the forward condition. Higher scores are better (Scale of 0 to 14).
Digit Span- LDSBBaseline and 12 WeeksDigit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Backward (LDSB) is the longest digit span participants got correct, in the backward condition. Higher scores are better (Scale of 0 to 8).
Digit Span- DSBBaseline and 12 WeeksDigit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSB) is the number of digit span trials participants got correct in the backward condition. Higher scores are better (Scale of 0 to 14).
CANTAB SST- SD CorrectBaseline and 12 WeeksThis is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. SD Correct is the standard deviation of response times across 'go' trials where the subject has responded on the correct button (right or left).

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Sugar Pill will be compared with the active medication Galantamine Placebo: Placebo dose.
32
Galantamine 8mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases. Galantamine: 8mg
31
Galantamine 16mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases. Galantamine: 16mg
30
Total93

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject10915

Baseline characteristics

CharacteristicPlaceboTotalGalantamine 16mgGalantamine 8mg
Age, Continuous48.1 years
STANDARD_DEVIATION 7.2
46.3 years
STANDARD_DEVIATION 7.6
43.3 years
STANDARD_DEVIATION 8.3
47.4 years
STANDARD_DEVIATION 6.8
Baseline Urine Positive
Benzodiazepines
1 Participants2 Participants0 Participants1 Participants
Baseline Urine Positive
Cocaine
29 Participants79 Participants27 Participants23 Participants
Baseline Urine Positive
Marijuana
4 Participants18 Participants4 Participants10 Participants
Education
High School
15 Participants48 Participants16 Participants17 Participants
Education
Less than High School
8 Participants25 Participants6 Participants11 Participants
Education
Some College or More
9 Participants20 Participants8 Participants3 Participants
Employment
Not Working
24 Participants69 Participants20 Participants25 Participants
Employment
Working
7 Participants21 Participants8 Participants6 Participants
Marital Status
Married
29 Participants79 Participants24 Participants26 Participants
Marital Status
Not Married
3 Participants14 Participants6 Participants5 Participants
Race/Ethnicity, Customized
African American
25 Participants62 Participants16 Participants21 Participants
Race/Ethnicity, Customized
Caucasian
3 Participants12 Participants5 Participants4 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants15 Participants9 Participants3 Participants
Race/Ethnicity, Customized
Multiracial
1 Participants4 Participants0 Participants3 Participants
Region of Enrollment
United States
32 Participants93 Participants30 Participants31 Participants
Sex: Female, Male
Female
12 Participants30 Participants9 Participants9 Participants
Sex: Female, Male
Male
20 Participants63 Participants21 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 310 / 30
other
Total, other adverse events
19 / 3213 / 3115 / 30
serious
Total, serious adverse events
0 / 320 / 310 / 30

Outcome results

Primary

Urine Toxicology

Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
PlaceboUrine Toxicology16.1 average cocaine positive urine samplesStandard Deviation 8
Galantamine 8mgUrine Toxicology17 average cocaine positive urine samplesStandard Deviation 9.4
Galantamine 16mgUrine Toxicology14.9 average cocaine positive urine samplesStandard Deviation 8.5
Secondary

Blood Pressure- Diastolic

Blood Pressure is taken for safety reasons

Time frame: 2 times a week for 12 weeks

Population: Data are reported for those that were measured at each assessment.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Pressure- DiastolicWeek 10 Time 178.32 mmHgStandard Deviation 9.18
PlaceboBlood Pressure- DiastolicWeek 4 Time 276.09 mmHgStandard Deviation 10.87
PlaceboBlood Pressure- DiastolicWeek 11 Time 276.36 mmHgStandard Deviation 13.17
PlaceboBlood Pressure- DiastolicWeek 6 Time 178.96 mmHgStandard Deviation 9.15
PlaceboBlood Pressure- DiastolicWeek 4 Time 177.75 mmHgStandard Deviation 10.61
PlaceboBlood Pressure- DiastolicWeek 1 Time 279.13 mmHgStandard Deviation 8.04
PlaceboBlood Pressure- DiastolicWeek 3 Time 274.59 mmHgStandard Deviation 9.59
PlaceboBlood Pressure- DiastolicWeek 2 Time 176.68 mmHgStandard Deviation 10.48
PlaceboBlood Pressure- DiastolicWeek 8 Time 276.90 mmHgStandard Deviation 10.23
PlaceboBlood Pressure- DiastolicWeek 3 Time 179.00 mmHgStandard Deviation 9.04
PlaceboBlood Pressure- DiastolicWeek 2 Time 277.46 mmHgStandard Deviation 9.07
PlaceboBlood Pressure- DiastolicWeek 6 Time 277.77 mmHgStandard Deviation 9.13
PlaceboBlood Pressure- DiastolicWeek 12 Time 179.76 mmHgStandard Deviation 10.72
PlaceboBlood Pressure- DiastolicWeek 8 Time 180.43 mmHgStandard Deviation 9.72
PlaceboBlood Pressure- DiastolicWeek 9 Time 1102.64 mmHgStandard Deviation 129.67
PlaceboBlood Pressure- DiastolicWeek 5 Time 276.48 mmHgStandard Deviation 9.28
PlaceboBlood Pressure- DiastolicWeek 7 Time 279.05 mmHgStandard Deviation 10.82
PlaceboBlood Pressure- DiastolicWeek 9 Time 274.86 mmHgStandard Deviation 9.24
PlaceboBlood Pressure- DiastolicWeek 1 Time 177.42 mmHgStandard Deviation 11.61
PlaceboBlood Pressure- DiastolicWeek 7 Time 179.05 mmHgStandard Deviation 9.92
PlaceboBlood Pressure- DiastolicWeek 10 Time 276.19 mmHgStandard Deviation 7.49
PlaceboBlood Pressure- DiastolicWeek 12 Time 274.90 mmHgStandard Deviation 12.48
PlaceboBlood Pressure- DiastolicWeek 5 Time 178.87 mmHgStandard Deviation 11.29
PlaceboBlood Pressure- DiastolicWeek 11 Time 180.95 mmHgStandard Deviation 9.32
Galantamine 8mgBlood Pressure- DiastolicWeek 9 Time 283.50 mmHgStandard Deviation 7.8
Galantamine 8mgBlood Pressure- DiastolicWeek 1 Time 178.75 mmHgStandard Deviation 9.71
Galantamine 8mgBlood Pressure- DiastolicWeek 5 Time 276.53 mmHgStandard Deviation 12.17
Galantamine 8mgBlood Pressure- DiastolicWeek 6 Time 180.63 mmHgStandard Deviation 13.08
Galantamine 8mgBlood Pressure- DiastolicWeek 8 Time 282.71 mmHgStandard Deviation 14.7
Galantamine 8mgBlood Pressure- DiastolicWeek 9 Time 174.67 mmHgStandard Deviation 12.82
Galantamine 8mgBlood Pressure- DiastolicWeek 10 Time 277.57 mmHgStandard Deviation 10.61
Galantamine 8mgBlood Pressure- DiastolicWeek 11 Time 180.57 mmHgStandard Deviation 12.18
Galantamine 8mgBlood Pressure- DiastolicWeek 11 Time 275.36 mmHgStandard Deviation 22.3
Galantamine 8mgBlood Pressure- DiastolicWeek 1 Time 275.75 mmHgStandard Deviation 11.8
Galantamine 8mgBlood Pressure- DiastolicWeek 2 Time 176.48 mmHgStandard Deviation 15.37
Galantamine 8mgBlood Pressure- DiastolicWeek 2 Time 280.70 mmHgStandard Deviation 11.85
Galantamine 8mgBlood Pressure- DiastolicWeek 3 Time 178.79 mmHgStandard Deviation 10.99
Galantamine 8mgBlood Pressure- DiastolicWeek 3 Time 279.50 mmHgStandard Deviation 11.15
Galantamine 8mgBlood Pressure- DiastolicWeek 4 Time 181.88 mmHgStandard Deviation 13.37
Galantamine 8mgBlood Pressure- DiastolicWeek 4 Time 281.67 mmHgStandard Deviation 12.12
Galantamine 8mgBlood Pressure- DiastolicWeek 5 Time 181.41 mmHgStandard Deviation 10.45
Galantamine 8mgBlood Pressure- DiastolicWeek 6 Time 280.43 mmHgStandard Deviation 10.45
Galantamine 8mgBlood Pressure- DiastolicWeek 7 Time 1132.31 mmHgStandard Deviation 200.73
Galantamine 8mgBlood Pressure- DiastolicWeek 7 Time 280.00 mmHgStandard Deviation 11.03
Galantamine 8mgBlood Pressure- DiastolicWeek 8 Time 179.50 mmHgStandard Deviation 8.63
Galantamine 8mgBlood Pressure- DiastolicWeek 10 Time 178.75 mmHgStandard Deviation 12.87
Galantamine 8mgBlood Pressure- DiastolicWeek 12 Time 181.46 mmHgStandard Deviation 8.92
Galantamine 8mgBlood Pressure- DiastolicWeek 12 Time 280.15 mmHgStandard Deviation 10.79
Galantamine 16mgBlood Pressure- DiastolicWeek 4 Time 280.13 mmHgStandard Deviation 10.07
Galantamine 16mgBlood Pressure- DiastolicWeek 10 Time 276.81 mmHgStandard Deviation 8.02
Galantamine 16mgBlood Pressure- DiastolicWeek 1 Time 179.54 mmHgStandard Deviation 7.55
Galantamine 16mgBlood Pressure- DiastolicWeek 10 Time 181.71 mmHgStandard Deviation 12.49
Galantamine 16mgBlood Pressure- DiastolicWeek 6 Time 283.22 mmHgStandard Deviation 9.33
Galantamine 16mgBlood Pressure- DiastolicWeek 9 Time 280.23 mmHgStandard Deviation 9.89
Galantamine 16mgBlood Pressure- DiastolicWeek 5 Time 180.13 mmHgStandard Deviation 8.27
Galantamine 16mgBlood Pressure- DiastolicWeek 7 Time 179.83 mmHgStandard Deviation 10.06
Galantamine 16mgBlood Pressure- DiastolicWeek 9 Time 181.27 mmHgStandard Deviation 7.75
Galantamine 16mgBlood Pressure- DiastolicWeek 12 Time 284.05 mmHgStandard Deviation 9.6
Galantamine 16mgBlood Pressure- DiastolicWeek 7 Time 281.09 mmHgStandard Deviation 10.92
Galantamine 16mgBlood Pressure- DiastolicWeek 8 Time 282.48 mmHgStandard Deviation 8.61
Galantamine 16mgBlood Pressure- DiastolicWeek 2 Time 279.42 mmHgStandard Deviation 10.7
Galantamine 16mgBlood Pressure- DiastolicWeek 2 Time 179.00 mmHgStandard Deviation 10.99
Galantamine 16mgBlood Pressure- DiastolicWeek 12 Time 184.00 mmHgStandard Deviation 10.87
Galantamine 16mgBlood Pressure- DiastolicWeek 3 Time 178.31 mmHgStandard Deviation 10.39
Galantamine 16mgBlood Pressure- DiastolicWeek 1 Time 280.88 mmHgStandard Deviation 10.53
Galantamine 16mgBlood Pressure- DiastolicWeek 8 Time 181.82 mmHgStandard Deviation 8.58
Galantamine 16mgBlood Pressure- DiastolicWeek 3 Time 278.35 mmHgStandard Deviation 10.02
Galantamine 16mgBlood Pressure- DiastolicWeek 11 Time 282.91 mmHgStandard Deviation 12.5
Galantamine 16mgBlood Pressure- DiastolicWeek 6 Time 180.57 mmHgStandard Deviation 10.12
Galantamine 16mgBlood Pressure- DiastolicWeek 4 Time 180.08 mmHgStandard Deviation 8.67
Galantamine 16mgBlood Pressure- DiastolicWeek 11 Time 185.05 mmHgStandard Deviation 13.6
Galantamine 16mgBlood Pressure- DiastolicWeek 5 Time 280.36 mmHgStandard Deviation 7.19
Secondary

Blood Pressure- Systolic

Blood Pressure is taken for safety reasons

Time frame: 2 times a week for 12 weeks

Population: Data are reported for those that were measured at each assessment.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Pressure- SystolicWeek 6 Time 2135.23 mmHgStandard Deviation 16.01
PlaceboBlood Pressure- SystolicWeek 6 Time 1131.04 mmHgStandard Deviation 17.66
PlaceboBlood Pressure- SystolicWeek 1 Time 1133.62 mmHgStandard Deviation 14.01
PlaceboBlood Pressure- SystolicWeek 2 Time 1132.92 mmHgStandard Deviation 14.89
PlaceboBlood Pressure- SystolicWeek 2 Time 2128.46 mmHgStandard Deviation 12.46
PlaceboBlood Pressure- SystolicWeek 3 Time 1132.29 mmHgStandard Deviation 13.81
PlaceboBlood Pressure- SystolicWeek 3 Time 2129.14 mmHgStandard Deviation 16.1
PlaceboBlood Pressure- SystolicWeek 4 Time 1129.42 mmHgStandard Deviation 15.34
PlaceboBlood Pressure- SystolicWeek 4 Time 2130.22 mmHgStandard Deviation 15.13
PlaceboBlood Pressure- SystolicWeek 5 Time 2134.67 mmHgStandard Deviation 16.21
PlaceboBlood Pressure- SystolicWeek 10 Time 1136.95 mmHgStandard Deviation 16.85
PlaceboBlood Pressure- SystolicWeek 10 Time 2132.52 mmHgStandard Deviation 13.13
PlaceboBlood Pressure- SystolicWeek 11 Time 2129.73 mmHgStandard Deviation 16.59
PlaceboBlood Pressure- SystolicWeek 12 Time 1131.57 mmHgStandard Deviation 15.1
PlaceboBlood Pressure- SystolicWeek 12 Time 2129.67 mmHgStandard Deviation 18.11
PlaceboBlood Pressure- SystolicWeek 1 Time 2132.04 mmHgStandard Deviation 14.27
PlaceboBlood Pressure- SystolicWeek 5 Time 1132.30 mmHgStandard Deviation 17.5
PlaceboBlood Pressure- SystolicWeek 7 Time 1133.68 mmHgStandard Deviation 12.44
PlaceboBlood Pressure- SystolicWeek 7 Time 2133.82 mmHgStandard Deviation 14.32
PlaceboBlood Pressure- SystolicWeek 8 Time 1136.43 mmHgStandard Deviation 19.92
PlaceboBlood Pressure- SystolicWeek 8 Time 2132.95 mmHgStandard Deviation 17
PlaceboBlood Pressure- SystolicWeek 9 Time 1140.95 mmHgStandard Deviation 43.91
PlaceboBlood Pressure- SystolicWeek 9 Time 2130.29 mmHgStandard Deviation 19.31
PlaceboBlood Pressure- SystolicWeek 11 Time 1133.86 mmHgStandard Deviation 14.23
Galantamine 8mgBlood Pressure- SystolicWeek 5 Time 2128.47 mmHgStandard Deviation 19.13
Galantamine 8mgBlood Pressure- SystolicWeek 9 Time 2130.43 mmHgStandard Deviation 14.48
Galantamine 8mgBlood Pressure- SystolicWeek 10 Time 1127.00 mmHgStandard Deviation 14.41
Galantamine 8mgBlood Pressure- SystolicWeek 11 Time 1125.79 mmHgStandard Deviation 18.65
Galantamine 8mgBlood Pressure- SystolicWeek 8 Time 1129.56 mmHgStandard Deviation 15.18
Galantamine 8mgBlood Pressure- SystolicWeek 11 Time 2125.71 mmHgStandard Deviation 12.13
Galantamine 8mgBlood Pressure- SystolicWeek 12 Time 1125.54 mmHgStandard Deviation 15.64
Galantamine 8mgBlood Pressure- SystolicWeek 12 Time 2131.85 mmHgStandard Deviation 14.28
Galantamine 8mgBlood Pressure- SystolicWeek 1 Time 1127.75 mmHgStandard Deviation 11.69
Galantamine 8mgBlood Pressure- SystolicWeek 8 Time 2133.00 mmHgStandard Deviation 15.96
Galantamine 8mgBlood Pressure- SystolicWeek 1 Time 2125.70 mmHgStandard Deviation 16.11
Galantamine 8mgBlood Pressure- SystolicWeek 6 Time 2124.21 mmHgStandard Deviation 10.53
Galantamine 8mgBlood Pressure- SystolicWeek 5 Time 1133.12 mmHgStandard Deviation 14.8
Galantamine 8mgBlood Pressure- SystolicWeek 2 Time 1125.62 mmHgStandard Deviation 12.58
Galantamine 8mgBlood Pressure- SystolicWeek 2 Time 2129.65 mmHgStandard Deviation 14.76
Galantamine 8mgBlood Pressure- SystolicWeek 10 Time 2121.07 mmHgStandard Deviation 19.86
Galantamine 8mgBlood Pressure- SystolicWeek 3 Time 1123.05 mmHgStandard Deviation 13.19
Galantamine 8mgBlood Pressure- SystolicWeek 7 Time 1121.50 mmHgStandard Deviation 15.84
Galantamine 8mgBlood Pressure- SystolicWeek 3 Time 2131.50 mmHgStandard Deviation 15.47
Galantamine 8mgBlood Pressure- SystolicWeek 6 Time 1125.94 mmHgStandard Deviation 15.28
Galantamine 8mgBlood Pressure- SystolicWeek 4 Time 1131.47 mmHgStandard Deviation 13.86
Galantamine 8mgBlood Pressure- SystolicWeek 9 Time 1121.93 mmHgStandard Deviation 13.05
Galantamine 8mgBlood Pressure- SystolicWeek 4 Time 2130.40 mmHgStandard Deviation 12.87
Galantamine 8mgBlood Pressure- SystolicWeek 7 Time 2125.27 mmHgStandard Deviation 15.4
Galantamine 16mgBlood Pressure- SystolicWeek 1 Time 2136.68 mmHgStandard Deviation 16.46
Galantamine 16mgBlood Pressure- SystolicWeek 5 Time 2133.27 mmHgStandard Deviation 15.71
Galantamine 16mgBlood Pressure- SystolicWeek 4 Time 1131.46 mmHgStandard Deviation 12.55
Galantamine 16mgBlood Pressure- SystolicWeek 9 Time 2133.50 mmHgStandard Deviation 17.32
Galantamine 16mgBlood Pressure- SystolicWeek 7 Time 2129.86 mmHgStandard Deviation 12.87
Galantamine 16mgBlood Pressure- SystolicWeek 4 Time 2131.00 mmHgStandard Deviation 13.16
Galantamine 16mgBlood Pressure- SystolicWeek 10 Time 1131.05 mmHgStandard Deviation 15.08
Galantamine 16mgBlood Pressure- SystolicWeek 9 Time 1135.32 mmHgStandard Deviation 14.36
Galantamine 16mgBlood Pressure- SystolicWeek 6 Time 2132.96 mmHgStandard Deviation 10.45
Galantamine 16mgBlood Pressure- SystolicWeek 8 Time 2134.76 mmHgStandard Deviation 14.74
Galantamine 16mgBlood Pressure- SystolicWeek 11 Time 1134.95 mmHgStandard Deviation 23.9
Galantamine 16mgBlood Pressure- SystolicWeek 3 Time 1130.58 mmHgStandard Deviation 17.35
Galantamine 16mgBlood Pressure- SystolicWeek 6 Time 1132.26 mmHgStandard Deviation 17.56
Galantamine 16mgBlood Pressure- SystolicWeek 11 Time 2136.18 mmHgStandard Deviation 16.28
Galantamine 16mgBlood Pressure- SystolicWeek 8 Time 1134.09 mmHgStandard Deviation 17.12
Galantamine 16mgBlood Pressure- SystolicWeek 2 Time 1130.69 mmHgStandard Deviation 13.56
Galantamine 16mgBlood Pressure- SystolicWeek 12 Time 1140.32 mmHgStandard Deviation 18.56
Galantamine 16mgBlood Pressure- SystolicWeek 10 Time 2128.00 mmHgStandard Deviation 15.7
Galantamine 16mgBlood Pressure- SystolicWeek 5 Time 1136.58 mmHgStandard Deviation 14.83
Galantamine 16mgBlood Pressure- SystolicWeek 12 Time 2134.62 mmHgStandard Deviation 11.38
Galantamine 16mgBlood Pressure- SystolicWeek 7 Time 1128.96 mmHgStandard Deviation 15.62
Galantamine 16mgBlood Pressure- SystolicWeek 1 Time 1132.21 mmHgStandard Deviation 13.68
Galantamine 16mgBlood Pressure- SystolicWeek 2 Time 2130.21 mmHgStandard Deviation 16.53
Galantamine 16mgBlood Pressure- SystolicWeek 3 Time 2129.00 mmHgStandard Deviation 28.65
Secondary

CANTAB RVIP Measure: RVP A

RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP A' (aka RVIP A PRIME): is a signal detection measure of target sensitivity (i.e., successful response to targets and withholding of responses to non-targets). Range of 0 to 1. Higher scores are better.

Time frame: Baseline and 12 Weeks

Population: complete case analysis at 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB RVIP Measure: RVP ABaseline.86 units on a scaleStandard Deviation 0.06
PlaceboCANTAB RVIP Measure: RVP AWeek 12.88 units on a scaleStandard Deviation 0.07
Galantamine 8mgCANTAB RVIP Measure: RVP ABaseline.86 units on a scaleStandard Deviation 0.05
Galantamine 8mgCANTAB RVIP Measure: RVP AWeek 12.84 units on a scaleStandard Deviation 0.12
Galantamine 16mgCANTAB RVIP Measure: RVP ABaseline.85 units on a scaleStandard Deviation 0.08
Galantamine 16mgCANTAB RVIP Measure: RVP AWeek 12.87 units on a scaleStandard Deviation 0.08
Secondary

CANTAB RVIP Measure: RVP B

RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP B: A measure of response bias (i.e., bias towards under-responding (to targets) versus over-responding (i.e., to non-targets)) range from -1 to +1, respectively.

Time frame: Baseline and 12 Weeks

Population: complete case analysis at 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB RVIP Measure: RVP BBaseline.77 units on a scaleStandard Deviation 0.42
PlaceboCANTAB RVIP Measure: RVP BWeek 12.77 units on a scaleStandard Deviation 0.42
Galantamine 8mgCANTAB RVIP Measure: RVP BBaseline.91 units on a scaleStandard Deviation 0.13
Galantamine 8mgCANTAB RVIP Measure: RVP BWeek 12.91 units on a scaleStandard Deviation 0.13
Galantamine 16mgCANTAB RVIP Measure: RVP BBaseline.77 units on a scaleStandard Deviation 0.22
Galantamine 16mgCANTAB RVIP Measure: RVP BWeek 12.77 units on a scaleStandard Deviation 0.22
Secondary

CANTAB RVIP Measure: RVP FALSE ALARM

RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP FALSE ALARM is probability of false alarm. False alarms are responses to non-targets. Higher numbers are worse (i.e., could be seen as a measure of poor response inhibition). Scores range from 0-1 where 1 is the least desirable probablity.

Time frame: Baseline and 12 Weeks

Population: complete case analysis at 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB RVIP Measure: RVP FALSE ALARMBaseline.04 units on a scaleStandard Deviation 0.08
PlaceboCANTAB RVIP Measure: RVP FALSE ALARMWeek 12.03 units on a scaleStandard Deviation 0.03
Galantamine 8mgCANTAB RVIP Measure: RVP FALSE ALARMBaseline.01 units on a scaleStandard Deviation 0.02
Galantamine 8mgCANTAB RVIP Measure: RVP FALSE ALARMWeek 12.03 units on a scaleStandard Deviation 0.04
Galantamine 16mgCANTAB RVIP Measure: RVP FALSE ALARMBaseline.03 units on a scaleStandard Deviation 0.04
Galantamine 16mgCANTAB RVIP Measure: RVP FALSE ALARMWeek 12.02 units on a scaleStandard Deviation 0.02
Secondary

CANTAB SST- Median Correct

This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. Median correct is the median of response times across 'go' trials where the subject has responded on the correct button (right or left).

Time frame: Baseline and 12 Weeks

Population: Complete cases analyzed at baseline and 12 weeks.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB SST- Median CorrectBaseline706.3 millisecondsStandard Deviation 260
PlaceboCANTAB SST- Median Correct12 Weeks608.6 millisecondsStandard Deviation 201.6
Galantamine 8mgCANTAB SST- Median CorrectBaseline619.7 millisecondsStandard Deviation 285.7
Galantamine 8mgCANTAB SST- Median Correct12 Weeks669.7 millisecondsStandard Deviation 323.5
Galantamine 16mgCANTAB SST- Median CorrectBaseline680.0 millisecondsStandard Deviation 631.5
Galantamine 16mgCANTAB SST- Median Correct12 Weeks631.5 millisecondsStandard Deviation 150.6
Secondary

CANTAB SST- SD Correct

This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. SD Correct is the standard deviation of response times across 'go' trials where the subject has responded on the correct button (right or left).

Time frame: Baseline and 12 Weeks

Population: Complete cases analyzed at baseline and 12 weeks.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB SST- SD CorrectBaseline276.5 millisecondsStandard Deviation 138.5
PlaceboCANTAB SST- SD Correct12 Weeks337.8 millisecondsStandard Deviation 262.9
Galantamine 8mgCANTAB SST- SD Correct12 Weeks410.6 millisecondsStandard Deviation 276.1
Galantamine 8mgCANTAB SST- SD CorrectBaseline302.3 millisecondsStandard Deviation 174.6
Galantamine 16mgCANTAB SST- SD CorrectBaseline363.4 millisecondsStandard Deviation 214.4
Galantamine 16mgCANTAB SST- SD Correct12 Weeks492.6 millisecondsStandard Deviation 530.5
Secondary

CANTAB SST- SSRT

This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'.

Time frame: Baseline and 12 Weeks

Population: Complete cases analyzed at baseline and 12 weeks.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCANTAB SST- SSRTBaseline215.3 millisecondsStandard Deviation 89.9
PlaceboCANTAB SST- SSRT12 Weeks241.9 millisecondsStandard Deviation 140.2
Galantamine 8mgCANTAB SST- SSRTBaseline277.2 millisecondsStandard Deviation 142.6
Galantamine 8mgCANTAB SST- SSRT12 Weeks267.9 millisecondsStandard Deviation 196.6
Galantamine 16mgCANTAB SST- SSRTBaseline244.1 millisecondsStandard Deviation 234.8
Galantamine 16mgCANTAB SST- SSRT12 Weeks234.8 millisecondsStandard Deviation 129.2
Secondary

Digit Span- DSB

Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSB) is the number of digit span trials participants got correct in the backward condition. Higher scores are better (Scale of 0 to 14).

Time frame: Baseline and 12 Weeks

Population: Complete cases at 12 weeks were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboDigit Span- DSBBaseline8.3 units on a scaleStandard Deviation 3.1
PlaceboDigit Span- DSB12 Weeks8.3 units on a scaleStandard Deviation 2.1
Galantamine 8mgDigit Span- DSBBaseline7.2 units on a scaleStandard Deviation 1.5
Galantamine 8mgDigit Span- DSB12 Weeks8.5 units on a scaleStandard Deviation 2.7
Galantamine 16mgDigit Span- DSBBaseline7.6 units on a scaleStandard Deviation 1.9
Galantamine 16mgDigit Span- DSB12 Weeks7.3 units on a scaleStandard Deviation 2.7
Secondary

Digit Span- DSF

Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSF) is the number of digit span trials participants got correct in the forward condition. Higher scores are better (Scale of 0 to 14).

Time frame: Baseline and 12 Weeks

Population: Complete cases at 12 weeks were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboDigit Span- DSFBaseline9.3 units on a scaleStandard Deviation 3
PlaceboDigit Span- DSF12 Weeks10.5 units on a scaleStandard Deviation 2.6
Galantamine 8mgDigit Span- DSFBaseline9.9 units on a scaleStandard Deviation 2.3
Galantamine 8mgDigit Span- DSF12 Weeks10.7 units on a scaleStandard Deviation 1.8
Galantamine 16mgDigit Span- DSFBaseline10.7 units on a scaleStandard Deviation 2.1
Galantamine 16mgDigit Span- DSF12 Weeks11.2 units on a scaleStandard Deviation 3.1
Secondary

Digit Span- LDSB

Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Backward (LDSB) is the longest digit span participants got correct, in the backward condition. Higher scores are better (Scale of 0 to 8).

Time frame: Baseline and 12 Weeks

Population: Complete cases at 12 weeks were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboDigit Span- LDSBBaseline4.2 units on a scaleStandard Deviation 1.7
PlaceboDigit Span- LDSB12 Weeks4.2 units on a scaleStandard Deviation 1.2
Galantamine 8mgDigit Span- LDSBBaseline3.2 units on a scaleStandard Deviation 0.9
Galantamine 8mgDigit Span- LDSB12 Weeks4.3 units on a scaleStandard Deviation 1.4
Galantamine 16mgDigit Span- LDSBBaseline4.0 units on a scaleStandard Deviation 1.7
Galantamine 16mgDigit Span- LDSB12 Weeks3.9 units on a scaleStandard Deviation 1.6
Secondary

Digit Span- LDSF

Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Forward (LDSF) is the longest digit span a participant gets correct, in the forward condition. Higher scores are better (Scale of 0 to 9).

Time frame: Baseline and 12 Weeks

Population: Complete cases at 12 weeks were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboDigit Span- LDSFBaseline5.9 units on a scaleStandard Deviation 1.7
PlaceboDigit Span- LDSF12 Weeks6.5 units on a scaleStandard Deviation 1.4
Galantamine 8mgDigit Span- LDSFBaseline5.7 units on a scaleStandard Deviation 1.3
Galantamine 8mgDigit Span- LDSF12 Weeks6.8 units on a scaleStandard Deviation 1
Galantamine 16mgDigit Span- LDSF12 Weeks7.4 units on a scaleStandard Deviation 1.2
Galantamine 16mgDigit Span- LDSFBaseline6.4 units on a scaleStandard Deviation 2.3
Secondary

Heart Rate

Pulse

Time frame: once a day for up to two days over 12 Weeks

Population: Summary data for only those measured at each week are presented (per protocol).

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboHeart RateWeek 580.91 beats per minute (bpm)Standard Deviation 10.59
PlaceboHeart RateWeek 280.24 beats per minute (bpm)Standard Deviation 13.61
PlaceboHeart RateWeek 1080.03 beats per minute (bpm)Standard Deviation 13.02
PlaceboHeart RateWeek 778.65 beats per minute (bpm)Standard Deviation 13.04
PlaceboHeart RateWeek 1281.07 beats per minute (bpm)Standard Deviation 10.49
PlaceboHeart RateWeek 1182.90 beats per minute (bpm)Standard Deviation 10.98
PlaceboHeart RateWeek 680.44 beats per minute (bpm)Standard Deviation 11.17
PlaceboHeart RateWeek 482.35 beats per minute (bpm)Standard Deviation 11.18
PlaceboHeart RateWeek 882.73 beats per minute (bpm)Standard Deviation 12.34
PlaceboHeart RateWeek 178.85 beats per minute (bpm)Standard Deviation 12.67
PlaceboHeart RateWeek 378.68 beats per minute (bpm)Standard Deviation 11.03
PlaceboHeart RateWeek 980.59 beats per minute (bpm)Standard Deviation 11.91
Galantamine 8mgHeart RateWeek 1180.51 beats per minute (bpm)Standard Deviation 11.16
Galantamine 8mgHeart RateWeek 675.55 beats per minute (bpm)Standard Deviation 10.08
Galantamine 8mgHeart RateWeek 780.50 beats per minute (bpm)Standard Deviation 9.03
Galantamine 8mgHeart RateWeek 877.46 beats per minute (bpm)Standard Deviation 10.46
Galantamine 8mgHeart RateWeek 981.31 beats per minute (bpm)Standard Deviation 9.81
Galantamine 8mgHeart RateWeek 1081.28 beats per minute (bpm)Standard Deviation 10.11
Galantamine 8mgHeart RateWeek 1276.33 beats per minute (bpm)Standard Deviation 7.47
Galantamine 8mgHeart RateWeek 177.76 beats per minute (bpm)Standard Deviation 9.24
Galantamine 8mgHeart RateWeek 279.74 beats per minute (bpm)Standard Deviation 10.62
Galantamine 8mgHeart RateWeek 380.42 beats per minute (bpm)Standard Deviation 8.15
Galantamine 8mgHeart RateWeek 477.83 beats per minute (bpm)Standard Deviation 7.56
Galantamine 8mgHeart RateWeek 578.82 beats per minute (bpm)Standard Deviation 9.25
Galantamine 16mgHeart RateWeek 978.09 beats per minute (bpm)Standard Deviation 10.15
Galantamine 16mgHeart RateWeek 474.84 beats per minute (bpm)Standard Deviation 8.52
Galantamine 16mgHeart RateWeek 277.13 beats per minute (bpm)Standard Deviation 10.62
Galantamine 16mgHeart RateWeek 878.56 beats per minute (bpm)Standard Deviation 10.02
Galantamine 16mgHeart RateWeek 675.80 beats per minute (bpm)Standard Deviation 10.08
Galantamine 16mgHeart RateWeek 374.98 beats per minute (bpm)Standard Deviation 10.86
Galantamine 16mgHeart RateWeek 1180.02 beats per minute (bpm)Standard Deviation 12.15
Galantamine 16mgHeart RateWeek 1080.02 beats per minute (bpm)Standard Deviation 12
Galantamine 16mgHeart RateWeek 776.48 beats per minute (bpm)Standard Deviation 10.76
Galantamine 16mgHeart RateWeek 1277.38 beats per minute (bpm)Standard Deviation 12.6
Galantamine 16mgHeart RateWeek 576.72 beats per minute (bpm)Standard Deviation 9.68
Galantamine 16mgHeart RateWeek 175.01 beats per minute (bpm)Standard Deviation 9.31
Secondary

Stroop- Effect Drug Neutral Mean Correct

Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. Stroop Effect is difference in response time to drug versus neutral trials (i.e., RT Correct Drug - RT Correct Neutral). A larger stroop effect is 'worse' (thought to indicate more attentional bias to drug related stimuli).

Time frame: weeks 0, 4, 8, 12, 16, 24, 36

Population: Data are reported for those that were assessed at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 43.71 millisecondsStandard Deviation 8.26
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 81.69 millisecondsStandard Deviation 4.24
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 24-1.44 millisecondsStandard Deviation 3.31
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 16-1.27 millisecondsStandard Deviation 4.02
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 122.36 millisecondsStandard Deviation 6.23
PlaceboStroop- Effect Drug Neutral Mean CorrectBaseline.22 millisecondsStandard Deviation 10.6
PlaceboStroop- Effect Drug Neutral Mean CorrectWeek 364.73 millisecondsStandard Deviation 5.53
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 42.31 millisecondsStandard Deviation 5.83
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectBaseline1.33 millisecondsStandard Deviation 5.21
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 24-0.53 millisecondsStandard Deviation 2.24
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 36-0.25 millisecondsStandard Deviation 1.56
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 16-0.56 millisecondsStandard Deviation 2.77
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 80.13 millisecondsStandard Deviation 3.4
Galantamine 8mgStroop- Effect Drug Neutral Mean CorrectWeek 12-0.12 millisecondsStandard Deviation 3.05
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 361.17 millisecondsStandard Deviation 4.11
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 40.92 millisecondsStandard Deviation 3.08
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectBaseline1.37 millisecondsStandard Deviation 4.09
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 8-0.12 millisecondsStandard Deviation 3.05
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 121.43 millisecondsStandard Deviation 3.81
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 16-0.87 millisecondsStandard Deviation 4.5
Galantamine 16mgStroop- Effect Drug Neutral Mean CorrectWeek 24-2.05 millisecondsStandard Deviation 3.04
Secondary

Stroop- RT Correct Drug

Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Drug is the mean response time to drug trials where the subject pressed the correct color response.

Time frame: weeks 0, 4, 8, 12, 16, 24, 36

Population: Data are reported for those that were assessed at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboStroop- RT Correct DrugBaseline795.40 millisecondsStandard Deviation 185.18
PlaceboStroop- RT Correct DrugWeek 16847.89 millisecondsStandard Deviation 272.23
PlaceboStroop- RT Correct DrugWeek 8819.39 millisecondsStandard Deviation 221.27
PlaceboStroop- RT Correct DrugWeek 12766.90 millisecondsStandard Deviation 181.53
PlaceboStroop- RT Correct DrugWeek 36829.28 millisecondsStandard Deviation 278.61
PlaceboStroop- RT Correct DrugWeek 24812.65 millisecondsStandard Deviation 254.72
PlaceboStroop- RT Correct DrugWeek 4825.09 millisecondsStandard Deviation 203.5
Galantamine 8mgStroop- RT Correct DrugWeek 8741.46 millisecondsStandard Deviation 168.87
Galantamine 8mgStroop- RT Correct DrugWeek 12755.87 millisecondsStandard Deviation 135.32
Galantamine 8mgStroop- RT Correct DrugBaseline806.57 millisecondsStandard Deviation 159.26
Galantamine 8mgStroop- RT Correct DrugWeek 4815.97 millisecondsStandard Deviation 182.08
Galantamine 8mgStroop- RT Correct DrugWeek 16802.33 millisecondsStandard Deviation 217.92
Galantamine 8mgStroop- RT Correct DrugWeek 24768.93 millisecondsStandard Deviation 189.97
Galantamine 8mgStroop- RT Correct DrugWeek 36747.40 millisecondsStandard Deviation 98.62
Galantamine 16mgStroop- RT Correct DrugWeek 16894.15 millisecondsStandard Deviation 136.44
Galantamine 16mgStroop- RT Correct DrugBaseline872.44 millisecondsStandard Deviation 190.94
Galantamine 16mgStroop- RT Correct DrugWeek 36990.59 millisecondsStandard Deviation 156.2
Galantamine 16mgStroop- RT Correct DrugWeek 24874.56 millisecondsStandard Deviation 229.66
Galantamine 16mgStroop- RT Correct DrugWeek 8829.90 millisecondsStandard Deviation 175.51
Galantamine 16mgStroop- RT Correct DrugWeek 4846.59 millisecondsStandard Deviation 165.73
Galantamine 16mgStroop- RT Correct DrugWeek 12817.91 millisecondsStandard Deviation 180.55
Secondary

Stroop- RT Correct Neutral

Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Neutral is the mean response time to neutral trials where the subject pressed the correct color response.

Time frame: weeks 0, 4, 8, 12, 16, 24, 36

Population: Data are reported for those that were assessed at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboStroop- RT Correct NeutralWeek 8817.69 millisecondsStandard Deviation 220.5
PlaceboStroop- RT Correct NeutralWeek 16849.17 millisecondsStandard Deviation 274.21
PlaceboStroop- RT Correct NeutralWeek 36824.54 millisecondsStandard Deviation 274.04
PlaceboStroop- RT Correct NeutralWeek 12764.53 millisecondsStandard Deviation 182.65
PlaceboStroop- RT Correct NeutralWeek 4821.37 millisecondsStandard Deviation 202.21
PlaceboStroop- RT Correct NeutralBaseline785.18 millisecondsStandard Deviation 183.55
PlaceboStroop- RT Correct NeutralWeek 24814.09 millisecondsStandard Deviation 255.82
Galantamine 8mgStroop- RT Correct NeutralBaseline805.24 millisecondsStandard Deviation 158.88
Galantamine 8mgStroop- RT Correct NeutralWeek 4813.66 millisecondsStandard Deviation 182.02
Galantamine 8mgStroop- RT Correct NeutralWeek 12756.00 millisecondsStandard Deviation 134.75
Galantamine 8mgStroop- RT Correct NeutralWeek 24769.47 millisecondsStandard Deviation 191.59
Galantamine 8mgStroop- RT Correct NeutralWeek 36747.65 millisecondsStandard Deviation 99.74
Galantamine 8mgStroop- RT Correct NeutralWeek 16802.90 millisecondsStandard Deviation 219.22
Galantamine 8mgStroop- RT Correct NeutralWeek 8741.33 millisecondsStandard Deviation 169.06
Galantamine 16mgStroop- RT Correct NeutralWeek 12816.47 millisecondsStandard Deviation 180.7
Galantamine 16mgStroop- RT Correct NeutralWeek 8830.22 millisecondsStandard Deviation 175.45
Galantamine 16mgStroop- RT Correct NeutralWeek 16895.03 millisecondsStandard Deviation 136.86
Galantamine 16mgStroop- RT Correct NeutralWeek 24876.61 millisecondsStandard Deviation 230.52
Galantamine 16mgStroop- RT Correct NeutralWeek 36989.42 millisecondsStandard Deviation 156.74
Galantamine 16mgStroop- RT Correct NeutralBaseline871.07 millisecondsStandard Deviation 191.15
Galantamine 16mgStroop- RT Correct NeutralWeek 4845.66 millisecondsStandard Deviation 164.98

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026