Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease

FORUM Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Central Nervous System Diseases; Cognition

Treatments: Drug: EVP-6124; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01073228

EVP-6124-010

Details and patient eligibility

About

This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

Full description

This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.

Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.

Enrollment: 409 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Probable Alzheimer's disease
• Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
• Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
• Female subjects are ≥1 year post-menopausal or are surgically sterile
• Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
• Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
• General health status acceptable for participation in a 24 week clinical trial be administered

Exclusion criteria

General

• Participation in another therapeutic clinical trial within 30 days before Baseline
• Prior participation in an amyloid vaccination clinical study
• Inability to swallow capsules
• Likely inability to complete 24 week study
• Inability to be ≥75% compliant with single-blind placebo run-in medication
• Inability to adequately perform cognitive tests
• History of significant cardiovascular disease
• Major depression
• Psychosis
• History of stroke within 18 months of screening
• Head trauma
• Inability to perform any screening or baseline evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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409 participants in 4 patient groups, including a placebo group

EVP-6124 0.3 mg

Active Comparator group

Description:

one 0.3 mg capsule every day for 183 days

Treatment:

Drug: EVP-6124

EVP-6124 1 mg

Active Comparator group

Description:

one 1 mg capsule every day for 183 days

Treatment:

Drug: EVP-6124

EVP-6124 2 mg

Active Comparator group

Description:

one 2 mg capsule every day for 183 days

Treatment:

Drug: EVP-6124

Placebo

Placebo Comparator group

Description:

Placebo every day for 183 days

Treatment:

Drug: Placebo