CompletedPhase 2

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

A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease

Lead sponsor

FORUM Pharmaceuticals Inc

Asset

EVP-6124

Listed sites

Recruiting sites

Enrollment

409

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR-SB ≥2•MMSE 14-24

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEVP-6124-010

NCT IDNCT01073228

Timeline

Milestones

Study first posted2010-02-23estimated

Study start2010-04 (month precision)

Primary completion2011-11actual (month precision)

Study completion2012-02actual (month precision)

Last update posted2014-04-25estimated

Assets

Drug assets

EVP-6124

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Executive function / language

Function / daily living

Behavior / neuropsychiatric

Global cognition

3 endpoints

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)

Time frame:Day -7, Baseline, 4, 12, 18, 23 Weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating Scale Sum of Boxes

Time frame:Day -7, Baseline, 4, 12, 18, 23 Weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Mini-Mental State Exam

Time frame:Day -7, Baseline, 4, 12, 18, 23 Weeks

Mini-Mental State Examination (MMSE)

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Controlled Oral Word Association Test

Time frame:Day -7, Baseline, 4, 12, 18, 23 Weeks

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study-Activities of Daily Living

Time frame:Baseline, 4, 12, 18, 23 Weeks

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric Inventory

Time frame:Baseline, 12, 23 Weeks

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale-Cognitive subscale-11

Time frame:4, 12, 18, 23 Weeks

descriptive

Secondary/protocol endpoint/low confidence

Category Fluency Test

Time frame:Day -7, Baseline, 4, 12, 18, 23 Weeks

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.