A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Dimebon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838110

B1451027

Details and patient eligibility

About

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

Enrollment: 742 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Alzheimer's Disease.
• MMSE 12-26 inclusive.
• If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
• If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion criteria

• Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
• Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
• Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
• Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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742 participants in 4 patient groups, including a placebo group

Dimebon 20 mg TID (Cohort 1)

Experimental group

Treatment:

Drug: Dimebon

Drug: Dimebon

Placebo TID (Cohort 1)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Dimebon 20 mg TID (Cohort 2)

Experimental group

Treatment:

Drug: Dimebon

Drug: Dimebon

Placebo TID (Cohort 2)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo