Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165750

Enrollment

Registered

2005-09-14

Start date

2005-03-31

Completion date

2008-11-30

Last updated

2013-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Interventions

DRUGDONEPEZIL HYDROCHLORIDE

One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Over 60 years old. 2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA. 3. MMSE score of 10\ 24, CDR of 1\ 2. 4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening. 5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

Exclusion criteria

1. Uncontrolled by donepezil because of adverse events. 2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc. 3. If they have taken concomitant medication which were not allowed.

Design outcomes

Primary

Measure	Time frame
MRI, ADAS-cog	0, 12, 24 weeks

Secondary

Measure	Time frame
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus	0, 12, 24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026