Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease
Brief summary
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
Interventions
DRUGDonepezil
2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
Sponsors
Eisai Korea Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 60 - 90 years old. 2. CDR: 0.5 - 2.0. 3. Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below. 4. Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below. 5. NINCDS-ADRDA criteria: Probable AD.
Exclusion criteria
1. Patients who have delusions and other conscious dysfunction. 2. Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination. 3. Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis. 4. Patients with severe cerebrovascular pathology. 5. Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria. 6. Patients who have history of alcoholism or drug addiction. 7. Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | 26 weeks | CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11). |
| CERAD-K | 26 weeks | CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatry Inventory (NPI) | 26 weeks | NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances. |
| GDS-K (Geriatric Depression Scale-Korean) Score After Treatment | 26 weeks | GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed. |
Countries
South Korea
Participant flow
Recruitment details
This study was recruited at 15 centers in Korea during the period of June 2006 to August 2008.
Participants by arm
| Arm | Count |
|---|---|
| Donepezil Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day. | 199 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 52 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Donepezil |
|---|---|
| Age, Continuous | 74.6 years STANDARD_DEVIATION 6.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 199 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 199 |
| serious Total, serious adverse events | 4 / 199 |
Outcome results
Primary
CERAD-K
CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.
Time frame: 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Donepezil | CERAD-K | Trail making test A | 206.64 Second | Standard Deviation 126.94 |
| Donepezil | CERAD-K | Trail making test B | 290.88 Second | Standard Deviation 30.2 |
Primary
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).
Time frame: 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Verbal Fluency | 8.28 Units on Scale | Standard Deviation 3.71 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Boston Naming Test | 7.31 Units on Scale | Standard Deviation 3.25 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | MMSE-KC | 17.86 Units on Scale | Standard Deviation 5.25 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Word List Memory | 10.62 Units on Scale | Standard Deviation 6.2 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Construction Praxis | 7.61 Units on Scale | Standard Deviation 2.71 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Word List Recall | 1.98 Units on Scale | Standard Deviation 1.99 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Word List Recognition | 4.64 Units on Scale | Standard Deviation 3.24 |
| Donepezil | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | Construction Recall | 2.11 Units on Scale | Standard Deviation 2.71 |
Secondary
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | GDS-K (Geriatric Depression Scale-Korean) Score After Treatment | 11.69 Units on Scale | Standard Deviation 6.42 |
Secondary
Neuropsychiatry Inventory (NPI)
NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.
Time frame: 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Donepezil | Neuropsychiatry Inventory (NPI) | Delusions | 0.49 Units on Scale | Standard Deviation 1.85 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Hallucinations | 0.12 Units on Scale | Standard Deviation 0.69 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Agitation | 0.54 Units on Scale | Standard Deviation 1.56 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Depression | 0.76 Units on Scale | Standard Deviation 1.82 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Anxiety | 0.70 Units on Scale | Standard Deviation 2.1 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Euphoria | 0.02 Units on Scale | Standard Deviation 0.19 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Apathy | 1.44 Units on Scale | Standard Deviation 2.69 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Disinhibition | 0.28 Units on Scale | Standard Deviation 1.19 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Irritability | 0.67 Units on Scale | Standard Deviation 1.93 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Aberrant motor behavior | 0.44 Units on Scale | Standard Deviation 1.71 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Night-time behaviors | 0.40 Units on Scale | Standard Deviation 1.68 |
| Donepezil | Neuropsychiatry Inventory (NPI) | Appetite and eating disorders | 0.43 Units on Scale | Standard Deviation 1.46 |