An Extension of the CONCERT Protocol (DIM18)

Alzheimer's Disease Clinical Trial

— CONCERT PLUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01152216
• Other study ID #: DIM18EXT
• Status: Terminated
• Phase: Phase 3
• First received: June 25, 2010
• Last updated: September 26, 2016
• Start date: April 2010

Study information

• Verified date: September 2016
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 672
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon
20 mg orally three times daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medivation, Inc.	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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.	Through study discontinuation	No