CompletedPhase 1

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

A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)

Lead sponsor

Medivation, Inc.

Asset

Dimebon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Safety and tolerability of orally administered dimebon

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDIM17

NCT IDNCT00829816

Timeline

Milestones

Study start2008-12 (month precision)

Study first posted2009-01-27estimated

Primary completion2009-04actual (month precision)

Study completion2010-08actual (month precision)

Last update posted2015-11-10estimated

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.

Time frame:up to 28 days

event count, event

Secondary/protocol endpoint

To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil.

Time frame:up to 28 days

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.