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

FORUM Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Alzheimer's Disease

Dementia

Treatments

Drug: EVP-6124

Study type

Interventional

Funder types

Industry

Identifiers

NCT02004392

EVP-6124-026

2013-002654-75 (EudraCT Number)

Details and patient eligibility

About

This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.

Enrollment

348 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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