Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Eisai

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00165724

EKI-1002

Details and patient eligibility

About

Open study for efficacy and safety of donepezil treatment during 48 weeks

Enrollment: 114 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Men or women aged 40 to 90
• Diagnosis of dementia according to DSM-IV
• Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
• Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
• Patients were generally healthy and ambulatory or ambulatory aided
• Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
• Patients have useful MRI results 3 months before screening

Exclusion

• If they have evidence of TIA or major infarction
• Epilepsy patients
• If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
• If they sensitive to acetylcholinesterase
• If they taken concomitant medication which were not allowed

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)