An Extension of the CONCERT Protocol (DIM18)

An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152216

Acronym

CONCERT PLUS

Enrollment

672

Registered

2010-06-29

Start date

2010-04-30

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

Alzheimer's Disease

Brief summary

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Interventions

DRUGDimebon

20 mg orally three times daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Successful completion of the 12 month DIM18 CONCERT study * Mild-to-moderate Alzheimer's disease * Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR) * Mini-Mental State Exam (MMSE) score between 12 and 24, 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
Safety	Through study discontinuation	To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.

Outcome results

None listed

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