NCT00381381

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

Completed Phase 4 Results posted Last updated 4 January 2022

What this trial tests

Phase 4 trial testing Donepezil in Alzheimer's Disease in 199 participants. Completed in 31 December 2008.

Timeline

31 May 2006

Primary endpoint
31 August 2008

31 December 2008

Quick facts

Lead sponsor	Eisai Korea Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	199
Start date	31 May 2006
Primary completion	31 August 2008
Estimated completion	31 December 2008
Sites	15 locations across South Korea

Drugs / interventions tested

• Donepezil (DONEPEZIL) — full drug profile →

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Eisai Korea Inc. — full company profile →

Who can join

Adults 60 to 90, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) Primary · 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).

Verbal Fluency

Group	Value	95% CI
Donepezil	8.28	± 3.71

Boston Naming Test

Group	Value	95% CI
Donepezil	7.31	± 3.25

MMSE-KC

Group	Value	95% CI
Donepezil	17.86	± 5.25

Word List Memory

Group	Value	95% CI
Donepezil	10.62	± 6.20

Construction Praxis

Group	Value	95% CI
Donepezil	7.61	± 2.71

Word List Recall

Group	Value	95% CI
Donepezil	1.98	± 1.99

Word List Recognition

Group	Value	95% CI
Donepezil	4.64	± 3.24

Construction Recall

Group	Value	95% CI
Donepezil	2.11	± 2.71

Neuropsychiatry Inventory (NPI) Secondary · 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.

Delusions

Group	Value	95% CI
Donepezil	0.49	± 1.85

Hallucinations

Group	Value	95% CI
Donepezil	0.12	± 0.69

Agitation

Group	Value	95% CI
Donepezil	0.54	± 1.56

Depression

Group	Value	95% CI
Donepezil	0.76	± 1.82

Anxiety

Group	Value	95% CI
Donepezil	0.70	± 2.10

Euphoria

Group	Value	95% CI
Donepezil	0.02	± 0.19

Apathy

Group	Value	95% CI
Donepezil	1.44	± 2.69

Disinhibition

Group	Value	95% CI
Donepezil	0.28	± 1.19

GDS-K (Geriatric Depression Scale-Korean) Score After Treatment Secondary · 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.

Group	Value	95% CI
Donepezil	11.69	± 6.42

CERAD-K Primary · 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.

Trail making test A

Group	Value	95% CI
Donepezil	206.64	± 126.94

Trail making test B

Group	Value	95% CI
Donepezil	290.88	± 30.20

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Donepezil

Serious: 4/199 (2%)

Deaths: —

Serious adverse events (5 terms)

Reaction	System	Donepezil
Anorexia	Psychiatric disorders	—
General Weakness	General disorders	—
Stroke	Vascular disorders	—
Ankle Fracture	Musculoskeletal and connective tissue disorders	—
Malignancy Of Unknown Origin	General disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Donepezil
Anorexia	Psychiatric disorders	—
Dizziness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Abdominal Discomfort	Gastrointestinal disorders	—
Weakness	General disorders	—
Vomiting	Gastrointestinal disorders	—

Most-reported serious reactions: Anorexia, General Weakness, Stroke, Ankle Fracture, Malignancy Of Unknown Origin.

Data from ClinicalTrials.gov NCT00381381 adverse events section.

Sponsor's own description

This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. siRNA drug delivery across the blood-brain barrier in Alzheimer's disease.
   Imran Sajid M, Sultan Sheikh F, Anis F, Nasim N, et al · · 2023 · cited 26× · PMID 37353152 · DOI 10.1016/j.addr.2023.114968
2. A data-driven approach to optimizing clinical study eligibility criteria.
   Fang Y, Liu H, Idnay B, Ta C, et al · · 2023 · cited 6× · PMID 37141977 · DOI 10.1016/j.jbi.2023.104375