Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, Galantamine, Dementia, Alzheimer type, Memory loss
Brief summary
The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).
Detailed description
This is a long-term (2-year), randomized (patients will be assigned to treatment by chance), double blind (neither the physician nor the patient will know which treatment is assigned) study of galantamine versus placebo in subjects with mild to moderately-severe AD. Approximately 2,000 patients will participate in this study. The study length for each patient is approximately 25.5 months. The study consists of 3 phases: a pretreatment phase, a treatment phase, and a posttreatment phase. The pretreatment phase includes a 2-week screening period (to obtain a patient's and his or her caregiver's informed consent and to confirm eligibility for the study) and a baseline visit at which subjects will be randomly assigned, in a 1 to 1 ratio, to receive either galantamine or placebo once a day in the morning. Study drug will first be dispensed at the baseline visit. The treatment phase is composed of a titration period (the study drug will be introduced gradually) and a maintenance period and includes 9 visits (3 of which are conducted by telephone). The titration period is 12 weeks long, and visits occur about every 28 days. In the first 4 weeks of the titration period, subjects will receive either 8 mg galantamine or matching placebo, and this dose will be increased to 16 mg galantamine or placebo in the second 4 weeks. The dose will then be increased to 24 mg galantamine or placebo for the final 4 weeks of the titration period if the investigator believes the subject will benefit from and will safely tolerate 24 mg/day. If not, the subject may continue to receive 16 mg galantamine or placebo through the end of the titration period. After the titration period, subjects will enter the maintenance period and continue to take study drug at the dosage they received at the end of the titration period. This dosage may be continued through the end of the study or may be changed once (either up from 16 to 24 mg or down from 24 to 16 mg), depending upon the benefit and the safety of such a change for the individual patient as judged by the investigator. No dosage will exceed 24 mg/day. The posttreatment phase includes an End-of-Study Visit that occurs at the end of the maintenance period. A follow-up telephone contact (interview) is conducted 1 month after the End-of-Study Visit. The effectiveness of galantamine will be evaluated using the following tools: the Mini-Mental State Examination (MMSE); the Disability Assessment in Dementia (DAD); and the Assessment of Patient Accommodation Status and Caregiver Burden (APAS CarB). Safety evaluations for the study include the monitoring of vital status and institutionalization status, adverse events, vital signs, weight, physical and neurologic examinations. A Data Safety Monitoring Board, external to the company, has been commissioned for this study to monitor the progress of the study and to ensure that the safety of patients is not compromised. The effectiveness hypothesis of this study is that galantamine, 16 to 24 mg per day, is superior to placebo in reducing cognitive decline from baseline (start of study drug) as measured by the MMSE over the course of 2 years. The safety hypothesis is that the mortality rate in the galantamine 16 to 24 mg per day treatment group will be the same as that in the placebo group over the course of 2 years.
Interventions
DRUGGalantamine
8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
DRUGPlacebo
Matching placebo
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients * diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition * living with or have regular and frequent visits from a responsible caregiver.
Exclusion criteria
* Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease * Any of specified conditions which may contribute to dementia * any of specified coexisting diseases, including significant cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Deaths Reported in Participants | Up to 2 years | An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised. |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 24 | The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants home with friend or relative using the APAS-CarB. |
| Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | The table below presents the number of days that caregiving activities were provided during the past week. |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 6 | The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Baseline, Month 24 | The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation \[each with a maximum score of 5\] was used). A higher score compared with baseline indicates less impairment. |
| Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Baseline, Month 24 | The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities. |
| Change From Baseline in Institutional Status | Baseline, Month 24 | This table describes the number of participants who were reported as institutionalized at baseline and Month 24. |
| Change From Baseline in Disability Assessment in Dementia (DAD) Scores | Baseline, Month 24 | The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities. |
Countries
Czechia, Estonia, France, Germany, Greece, Latvia, Lithuania, Romania, Russia, Slovakia, Slovenia, Ukraine
Participant flow
Recruitment details
This study investigated the benefits and risks of long-term galantamine use in participants with Alzheimer's Disease. The study was conducted from 19 May 2008 to 20 May 2012 at 127 clinical centers in 13 countries. A total of 2051 participants were randomized to study treatment, of these 2045 received at least 1 dose of treatment.
Pre-assignment details
The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group. | 1,021 |
| Galantamine During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability. | 1,024 |
| Total | 2,045 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 43 | 53 |
| Overall Study | Death | 41 | 29 |
| Overall Study | Early Study Closure | 425 | 405 |
| Overall Study | Lost to Follow-up | 22 | 26 |
| Overall Study | Withdrawal by Subject | 168 | 172 |
Baseline characteristics
| Characteristic | Placebo | Galantamine | Total |
|---|---|---|---|
| Age Continuous | 73.2 participants STANDARD_DEVIATION 8.67 | 73 participants STANDARD_DEVIATION 8.88 | 73.1 participants STANDARD_DEVIATION 8.77 |
| Age, Customized <61 | 112 participants | 112 participants | 224 participants |
| Age, Customized 61-<76 | 467 participants | 466 participants | 933 participants |
| Age, Customized >=76 | 442 participants | 446 participants | 888 participants |
| Region of Enrollment Czech Republic | 33 participants | 34 participants | 67 participants |
| Region of Enrollment Estonia | 53 participants | 51 participants | 104 participants |
| Region of Enrollment France | 10 participants | 11 participants | 21 participants |
| Region of Enrollment Germany | 218 participants | 221 participants | 439 participants |
| Region of Enrollment Greece | 35 participants | 36 participants | 71 participants |
| Region of Enrollment Italy | 25 participants | 24 participants | 49 participants |
| Region of Enrollment Latvia | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Lithuania | 23 participants | 21 participants | 44 participants |
| Region of Enrollment Romania | 84 participants | 84 participants | 168 participants |
| Region of Enrollment Russia | 274 participants | 271 participants | 545 participants |
| Region of Enrollment Slovakia | 85 participants | 88 participants | 173 participants |
| Region of Enrollment Slovenia | 13 participants | 13 participants | 26 participants |
| Region of Enrollment Ukraine | 166 participants | 168 participants | 334 participants |
| Sex: Female, Male Female | 654 Participants | 671 Participants | 1325 Participants |
| Sex: Female, Male Male | 367 Participants | 353 Participants | 720 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 115 / 1,021 | 168 / 1,024 |
| serious Total, serious adverse events | 123 / 1,021 | 129 / 1,024 |
Outcome results
Primary
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Time frame: Baseline, Month 24
Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | -2.14 Scores on scale | Standard Deviation 4.34 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | -1.41 Scores on scale | Standard Deviation 4.05 |
p-value: <0.001ANCOVA
Primary
The Number of Deaths Reported in Participants
An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.
Time frame: Up to 2 years
Population: The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Number of Deaths Reported in Participants | 56 Number of Participants |
| Galantamine | The Number of Deaths Reported in Participants | 33 Number of Participants |
p-value: 0.01195% CI: [0.37, 0.89]Regression, Cox
Secondary
Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
The table below presents the number of days that caregiving activities were provided during the past week.
Time frame: Baseline, Months 12 and 24
Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Baseline | 5.91 Days | Standard Deviation 2.094 |
| Placebo | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Month 12 | 6.06 Days | Standard Deviation 1.964 |
| Placebo | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Month 24 | 6.13 Days | Standard Deviation 1.952 |
| Galantamine | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Baseline | 5.77 Days | Standard Deviation 2.241 |
| Galantamine | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Month 12 | 6.07 Days | Standard Deviation 1.969 |
| Galantamine | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Provided caregiving during past week - Month 24 | 6.20 Days | Standard Deviation 1.83 |
Secondary
Change From Baseline in Disability Assessment in Dementia (DAD) Scores
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Time frame: Baseline, Month 24
Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Disability Assessment in Dementia (DAD) Scores | -10.81 Scores on scale | Standard Deviation 18.268 |
| Galantamine | Change From Baseline in Disability Assessment in Dementia (DAD) Scores | -8.16 Scores on scale | Standard Deviation 17.251 |
p-value: 0.002ANCOVA
Secondary
Change From Baseline in Institutional Status
This table describes the number of participants who were reported as institutionalized at baseline and Month 24.
Time frame: Baseline, Month 24
Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Institutional Status | Baseline | 1 Number of Participants |
| Placebo | Change From Baseline in Institutional Status | Month 24 | 5 Number of Participants |
| Galantamine | Change From Baseline in Institutional Status | Baseline | 0 Number of Participants |
| Galantamine | Change From Baseline in Institutional Status | Month 24 | 6 Number of Participants |
p-value: 0.269Cochran-Mantel-Haenszel
p-value: 0.835Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants home with friend or relative using the APAS-CarB.
Time frame: Baseline, Months 12 and 24
Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Month 12 | 61.4 Percentage of participants |
| Placebo | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Month 24 | 55.3 Percentage of participants |
| Placebo | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Baseline | 62.1 Percentage of participants |
| Galantamine | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Baseline | 62.8 Percentage of participants |
| Galantamine | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Month 12 | 61.8 Percentage of participants |
| Galantamine | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Home with friend or relative - Month 24 | 60.1 Percentage of participants |
Secondary
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Time frame: Baseline, Month 24
Population: This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Planning and Organization | -13.14 Scores on scale | Standard Deviation 24.565 |
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Basic | -14.24 Scores on scale | Standard Deviation 24.093 |
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Effective Performance | -13.82 Scores on scale | Standard Deviation 21.975 |
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Instrumental | -13.52 Scores on scale | Standard Deviation 23.21 |
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Leisure | -13.02 Scores on scale | Standard Deviation 35.37 |
| Placebo | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Initiation | -13.53 Scores on scale | Standard Deviation 22.993 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Leisure | -10.46 Scores on scale | Standard Deviation 32.769 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Effective Performance | -10.82 Scores on scale | Standard Deviation 19.959 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Basic | -9.84 Scores on scale | Standard Deviation 21.899 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Instrumental | -10.72 Scores on scale | Standard Deviation 21.714 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Initiation | -9.60 Scores on scale | Standard Deviation 20.66 |
| Galantamine | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Planning and Organization | -9.96 Scores on scale | Standard Deviation 23.154 |
p-value: 0.01ANCOVA
p-value: 0.043ANCOVA
p-value: 0.018ANCOVA
p-value: 0.005ANCOVA
p-value: 0.054ANCOVA
p-value: 0.137ANCOVA
Secondary
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Time frame: Baseline, Month 6
Population: An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | -0.28 Scores on scale | Standard Deviation 2.938 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | 0.15 Scores on scale | Standard Deviation 2.725 |
p-value: <0.001ANCOVA
Secondary
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation \[each with a maximum score of 5\] was used). A higher score compared with baseline indicates less impairment.
Time frame: Baseline, Month 24
Population: The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Language | -0.93 Scores on scale | Standard Deviation 1.895 |
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Attention and Calculation | -0.46 Scores on scale | Standard Deviation 1.526 |
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Registration | -0.20 Scores on scale | Standard Deviation 0.771 |
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Recall | 0.00 Scores on scale | Standard Deviation 1.013 |
| Placebo | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Orientation | -0.96 Scores on scale | Standard Deviation 2.32 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Recall | 0.10 Scores on scale | Standard Deviation 1.07 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Language | -0.68 Scores on scale | Standard Deviation 1.867 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Orientation | -0.76 Scores on scale | Standard Deviation 2.128 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Registration | -0.16 Scores on scale | Standard Deviation 0.692 |
| Galantamine | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Attention and Calculation | -0.16 Scores on scale | Standard Deviation 1.561 |
p-value: 0.194ANCOVA
p-value: 0.353ANCOVA
p-value: 0.009ANCOVA
p-value: 0.158ANCOVA
p-value: 0.088ANCOVA