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

Eisai

Status and phase: Terminated; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: DONEPEZIL HYDROCHLORIDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00165750

AS-019 (EKI-5-003)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

1

Experimental group

Treatment:

Drug: DONEPEZIL HYDROCHLORIDE