Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil

Medivation

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Dimebon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829816

DIM17

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.

Enrollment: 46 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alzheimer's disease
• On Memantine
• Caregiver who is willing to accompany the patient to all clinic visits

Exclusion criteria

• Unstable medical illnesses or significant hepatic or renal disease
• Other primary psychiatric or neurological disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Dimebon

Experimental group

Description:

20 mg dimebon by mouth 3 times per day

Treatment:

Drug: Dimebon

Placebo

Placebo Comparator group

Description:

20 mg placebo by mouth 3 times per day

Treatment:

Drug: Placebo