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TerminatedPhase 3

Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025

A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects With Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

Lead sponsor

FORUM Pharmaceuticals Inc

Asset

EVP-6124

Listed sites

Recruiting sites

Enrollment

348

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Safety of 2 fixed doses of EVP-6124 for up

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

Eudract number2013-002654-75

Org study IDEVP-6124-026

NCT IDNCT02004392

Timeline

Milestones

Study first posted2013-12-09estimated

Study start2014-06 (month precision)

Last update posted2016-05-03estimated

Primary completion2017-08estimated (month precision)

Study completion2017-08estimated (month precision)

Assets

Drug assets

EVP-6124

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025

•Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures

•Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025

•No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025

•In the judgment of the investigator, extension treatment is in the best interest of the subject

•Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method])

•Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible

Exclusion criteria

•Significant risk of suicidal or violent behavior in the judgment of the investigator

•Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation

•Any condition that would make the subject in the judgment of the investigator unsuitable for the study

•Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study

Endpoints (6)

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

Caregiver / quality of life

Global cognition

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

1 endpoint

Secondary/protocol endpoint

Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)

Time frame:Baseline to Day 182 or Early Termination

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)

Time frame:Baseline to Day 182 or Early Termination

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

3 endpoints

Secondary/protocol endpoint

Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)

Time frame:Baseline to Day 182 or Early Termination

change from baseline, improvement

Secondary/protocol endpoint

Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)

Time frame:Baseline to Day 182 or Early Termination

descriptive

Secondary/protocol endpoint

Caregiver perceived burden using the Zarit Burden Interview (ZBI)

Time frame:Baseline to Day 182 or Early Termination

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimer's disease who complete study EVP-6124-024 or EVP-6124-025

Time frame:Baseline to Day 182 or Early Termination

event count, event

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.