Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, Galantamine, Dementia
Brief summary
This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.
Detailed description
This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated.
Interventions
DRUGGalantamine
Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA * K-MMSE (Korean - Mini Mental State Exam) is 10 to 24 * Reliable Guardian available to the patients * Patient or guardian provided written informed consent before entering into the clinical trial
Exclusion criteria
* Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial * Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome) * Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock) * brain tumor, nerve syphilis, meningitis, encephalitis * epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Simple Reaction Time | Baseline, Week 12 | The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes. |
| Change From Baseline in Choice Reaction Time | Baseline, Week 12 | The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | Baseline, Week 12 | The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening. |
| Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K) | Baseline, Week 12 | DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function |
| Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL) | Baseline, Week 12 | The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning. |
Participant flow
Recruitment details
Of the total of 99 enrolled patients, only 92 were screened.
Participants by arm
| Arm | Count |
|---|---|
| Galantamine 8 mg/day for 4 weeks; 16 mg/day thereafter | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Other | 8 |
| Overall Study | Uncooperative participations to study | 7 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Galantamine |
|---|---|
| Age Continuous | 73.24 Years STANDARD_DEVIATION 7.969 |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 92 |
| serious Total, serious adverse events | 8 / 92 |
Outcome results
Primary
Change From Baseline in Choice Reaction Time
The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.
Time frame: Baseline, Week 12
Population: Per-protocol (PP) analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Galantamine | Change From Baseline in Choice Reaction Time | Week 4 (n=80) | 429.54 seconds | Standard Deviation 3388 |
| Galantamine | Change From Baseline in Choice Reaction Time | Week 12 (n=73) | 1331 seconds | Standard Deviation 3627 |
Primary
Change From Baseline in Simple Reaction Time
The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.
Time frame: Baseline, Week 12
Population: Per-protocol (PP) analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Galantamine | Change From Baseline in Simple Reaction Time | Week 4 (n=83) | -30.92 seconds | Standard Deviation 1277 |
| Galantamine | Change From Baseline in Simple Reaction Time | Week 12 (n=73) | 180.83 seconds | Standard Deviation 519.18 |
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.
Time frame: Baseline, Week 12
Population: Intention-to-Treat analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | 1.31 scores on a scale | Standard Deviation 5.67 |
Secondary
Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)
DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function
Time frame: Baseline, Week 12
Population: Intention-to-Treat analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K) | -1.41 scores on a scale | Standard Deviation 10.53 |
Secondary
Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)
The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.
Time frame: Baseline, Week 12
Population: Intention-to-Treat analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galantamine | Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL) | 1.22 scores on a scale | Standard Deviation 6.88 |