Study of the safety and effectiveness of investigational studydrug EVP-6124 in subjects with Alzheimer's Disease

• Conditions: Alzheimer’s Disease; MedDRA version: 18.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-002654-75-BE
• Lead Sponsor: Forum Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-02
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1580

Inclusion Criteria

1. 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 extension procedures
2. Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
3. 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
4. In the judgment of the investigator, extension treatment is in the best interest of the subject
5. 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 Protocol EVP-6124-026; 12 September 2013 Page 9 of 66 Forum Pharmaceuticals Inc. CONFIDENTIAL EVP-6124 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])
6. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1422

Exclusion Criteria

1. Significant risk of suicidal or violent behavior in the judgment of the investigator
2. Adverse events (AEs) 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
3. Any condition that would make the subject in the judgment of the investigator unsuitable for the study
4. Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified