Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: SAM-531 5.0 mg; Drug: SAM-531 3.0 mg; Drug: Placebo; Drug: SAM-531 1.5 mg; Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00895895

B1961007

3193A1-2005

Details and patient eligibility

About

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

Full description

The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

Enrollment: 526 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
• Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
• Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.

Exclusion criteria

• Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
• Current major depressive disorder or other current major psychiatric disorder.
• History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
• Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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526 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

SAM-531 1.5 mg

Treatment:

Drug: SAM-531 1.5 mg

3

Experimental group

Description:

SAM-531 3.0 mg

Treatment:

Drug: SAM-531 3.0 mg

4

Experimental group

Description:

SAM-531 5.0 mg

Treatment:

Drug: SAM-531 5.0 mg

5

Active Comparator group

Description:

Donepezil

Treatment:

Drug: Donepezil