A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Alzheimer's Disease; Investigational Drug; Dementia; Dimebon

Treatments: Drug: PF-01913539 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066481

B1451010

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild-to-Moderate Alzheimer's disease
• MMSE score 10-24 inclusive

Exclusion criteria

• Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
• Complication of other causes of dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

PF-01913539 5 mg three times daily

Experimental group

Description:

PF-01913539 5 mg three times daily for 6 months

Treatment:

Drug: PF-01913539 5 mg

Drug: PF-01913539 5 mg

PF-01913539 20 mg three times daily

Experimental group

Description:

PF-01913539 20 mg three times daily for 6 months

Treatment:

Drug: PF-01913539 5 mg

Drug: PF-01913539 5 mg

Placebo

Placebo Comparator group

Description:

Placebo three times daily for 6 months

Treatment:

Drug: Placebo