An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Dimebon tablet for oral administration

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066546

B1451030

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

Full description

This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Enrollment: 5 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion criteria

• Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Dimebon

Experimental group

Treatment:

Drug: Dimebon tablet for oral administration