Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Alzheimer's Disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osaka City University

Criteria

Inclusion Criteria:

• Japanese patients who are diagnosed as probable Alzheimer' Disease according to NINCDS-ADRDA criteria

• Diagnosed by brain diagnostic imaging (CT, MRI) within six months before the consent and no occurrence of the event after that to suggest cerebral vascular disease

• Mild to Moderate Alzheimer's Disease of MMSE from 10 to 26

• Age from 55 to 80

• Treated for a minimum of 12 weeks with a stable dose of donepezil and willing to continue the same during the trial period

• For women Menopause ≥ 2 years

• For men contraceptive measures are required during the study and after 6 months

• In principle patients should be living at their home in the presence of a caregiver who is defined as a healthy person in contact with the patient for more than 10 hours a week, could provide required information of the behavior and activities of daily living, accompany all the clinical examination, and supervise the handling and administration of the drug throughout the study period.

• Patients who could take pills as a whole

• Patient, caregiver and patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form

Exclusion Criteria:

• Any cause of dementia not due to Alzheimer's disease

• Past history of other central nervous condition or psychiatric disease

• Symptom of depression and drug addiction

• Impairment in the physical function by other factor than the Alzheimer's Disease

• Patients who are expected to move in to care facilities during the study period

• triglyceride > 400 mg/dL