A Continuation of the CONCERT Study of Patients with Alzheimer's Disease Where All Patients Receive Study Drug

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-018121-75-DE

Enrollment

850

Registered

2010-06-16

Start date

2010-09-24

Completion date

Unknown

Last updated

2013-03-04

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

Conditions

Alzheimer's Disease MedDRA version: 14.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Dimebon Product Code: Dimebon Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Dimebon dihydrochloride CAS Number: 97657-92-6 Current Sponsor code: Dimebon Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) study. 2. Are willing and able to give informed consent for study participation; 3. Have a caregiver who assists the patient, can oversee study drug administration, report adverse events, and provide written informed consent; 4. Are capable of complying with study procedures, including being able to swallow the study drug tablets. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 142 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 861

Exclusion criteria

Exclusion criteria: 1. Have any major medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, which places the patient at undue risk, or may interfere with the ability to interpret safety information;

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: None;Primary end point(s): The safety of dimebon will be assessed by the frequency of serious adverse events, the frequency of discontinuation of dimebon treatment due to an adverse event, the frequency and severity of adverse events, as well as the frequency of new laboratory abnormalities. Safety measures include adverse events and clinical laboratory studies.;Timepoint(s) of evaluation of this end point: Final analysis will be conducted upon marketing authorisation or termination of the trial.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: None;Primary end point(s): The safety of dimebon will be assessed by the frequency of serious adverse events, the frequency of discontinuation of dimebon treatment due to an adverse event, the frequency and severity of adverse events, as well as the frequency of new laboratory abnormalities. Safety measures include adverse events and clinical laboratory studies.;Timepoint(s) of evaluation of this end point: Final analysis will be conducted upon marketing authorisation or termination of the trial.

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Australia, Belgium, Finland, Germany, Italy, New Zealand, Sweden, United Kingdom, United States

Contacts

Public ContactSenior Director Clinical Operations

Medivation

info@medivation.com1415543-3470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026