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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165750
• Other study ID #: AS-019 (EKI-5-003)
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 19, 2013
• Start date: March 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Cheonnam University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI, ADAS-cog		0, 12, 24 weeks	Yes
Secondary	ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus		0, 12, 24 weeks	No