A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease

CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954590

Acronym

CONTACT

Enrollment

Registered

2009-08-07

Start date

2009-10-31

Completion date

Unknown

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Alzheimer

Brief summary

The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

Interventions

DRUGDimebon (latrepirdine)

20 mg orally three times daily

DRUGPlacebo

Placebo orally three times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderate-to-Severe Alzheimer's disease * Mini-Mental State Examination (MMSE) Score between 5 to 14, inclusive * Stable on donepezil for at least 6 months

Exclusion criteria

* Other causes of dementia * Major structural brain disease * Unstable medical condition or significant hepatic or renal disease

Design outcomes

Primary

Measure	Time frame	Description
Neuropsychiatric Inventory (NPI)	26 weeks post baseline	To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
Activities of Daily Living (severe) (ADCS ADLsev)	26 weeks post baseline	To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev).

Countries

Chile, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026