Phase 4
Completed N=199
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Source: ClinicalTrials.gov NCT00381381 ↗Enrolled (actual)
199
Serious AEs
2.0%
Results posted
Jul 2012
Primary outcomePrimary: CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) — 8.28; 7.31; 17.86; 10.62 Units on Scale
Summary
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) |
8.28; 7.31; 17.86; 10.62; 7.61; 1.98 | — |
| PRIMARY CERAD-K |
206.64; 290.88 | — |
| SECONDARY Neuropsychiatry Inventory (NPI) |
0.49; 0.12; 0.54; 0.76; 0.70; 0.02 | — |
| SECONDARY GDS-K (Geriatric Depression Scale-Korean) Score After Treatment |
11.69 | — |
Eligibility Criteria
Inclusion criteria
- Age: 60 - 90 years old.
- CDR: 0.5 - 2.0.
- Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
- Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
- NINCDS-ADRDA criteria: Probable AD.
Exclusion criteria
- Patients who have delusions and other conscious dysfunction.
- Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
- Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
- Patients with severe cerebrovascular pathology.
- Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
- Patients who have history of alcoholism or drug addiction.
- Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Data sourced from ClinicalTrials.gov (NCT00381381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.