A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)

Medivation

Status and phase: Terminated; Phase 3

Conditions: Moderate to Severe Alzheimer

Treatments: Drug: Dimebon (latrepirdine); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00954590

DIM19

Details and patient eligibility

About

The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

Enrollment: 89 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate-to-Severe Alzheimer's disease
• Mini-Mental State Examination (MMSE) Score between 5 to 14, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 2 patient groups, including a placebo group

Dimebon (latrepirdine)

Experimental group

Description:

Dimebon, 20 mg orally three times daily

Treatment:

Drug: Dimebon (latrepirdine)

Placebo

Placebo Comparator group

Description:

Placebo orally three times daily

Treatment:

Drug: Placebo