Trial Outcomes & Findings for The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease (NCT NCT00381381)

Last Updated: 2022-01-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

199 participants

Primary outcome timeframe

26 weeks

Results posted on

2022-01-04

Participant Flow

This study was recruited at 15 centers in Korea during the period of June 2006 to August 2008.

Participant milestones

Participant milestones
Measure	Donepezil Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Overall Study STARTED	199
Overall Study COMPLETED	135
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Donepezil Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	52
Overall Study Withdrawal by Subject	9

Baseline Characteristics

The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donepezil n=199 Participants Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Age, Continuous	74.6 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	199 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Outcome measures

Outcome measures
Measure	Donepezil n=135 Participants Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
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
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
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
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 6.20
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
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
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
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Donepezil n=135 Participants Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
CERAD-K Trail making test A	206.64 Second Standard Deviation 126.94
CERAD-K Trail making test B	290.88 Second Standard Deviation 30.20

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Donepezil n=135 Participants Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Neuropsychiatry Inventory (NPI) Delusions	0.49 Units on Scale Standard Deviation 1.85
Neuropsychiatry Inventory (NPI) Hallucinations	0.12 Units on Scale Standard Deviation 0.69
Neuropsychiatry Inventory (NPI) Agitation	0.54 Units on Scale Standard Deviation 1.56
Neuropsychiatry Inventory (NPI) Depression	0.76 Units on Scale Standard Deviation 1.82
Neuropsychiatry Inventory (NPI) Anxiety	0.70 Units on Scale Standard Deviation 2.10
Neuropsychiatry Inventory (NPI) Euphoria	0.02 Units on Scale Standard Deviation 0.19
Neuropsychiatry Inventory (NPI) Apathy	1.44 Units on Scale Standard Deviation 2.69
Neuropsychiatry Inventory (NPI) Disinhibition	0.28 Units on Scale Standard Deviation 1.19
Neuropsychiatry Inventory (NPI) Irritability	0.67 Units on Scale Standard Deviation 1.93
Neuropsychiatry Inventory (NPI) Aberrant motor behavior	0.44 Units on Scale Standard Deviation 1.71
Neuropsychiatry Inventory (NPI) Night-time behaviors	0.40 Units on Scale Standard Deviation 1.68
Neuropsychiatry Inventory (NPI) Appetite and eating disorders	0.43 Units on Scale Standard Deviation 1.46

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Donepezil n=135 Participants Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment	11.69 Units on Scale Standard Deviation 6.42

Adverse Events

Donepezil

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Donepezil n=199 participants at risk Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Psychiatric disorders Anorexia	0.50% 1/199 • Number of events 1
General disorders General Weakness	0.50% 1/199 • Number of events 1
Vascular disorders Stroke	0.50% 1/199 • Number of events 1
Musculoskeletal and connective tissue disorders Ankle Fracture	0.50% 1/199 • Number of events 1
General disorders Malignancy Of Unknown Origin	0.50% 1/199 • Number of events 1

Other adverse events

Other adverse events
Measure	Donepezil n=199 participants at risk Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
General disorders Weakness	1.5% 3/199
Psychiatric disorders Anorexia	3.5% 7/199
Gastrointestinal disorders Abdominal Discomfort	2.0% 4/199
Gastrointestinal disorders Vomiting	1.0% 2/199
Gastrointestinal disorders Nausea	2.5% 5/199
Nervous system disorders Dizziness	3.5% 7/199
Nervous system disorders Headache	2.5% 5/199

Additional Information

Jihee Mun, Pharmacist, Medical team manager

Eisai Korea Inc.

Phone: +82-2-3451-5531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place