Clinical trial NCT02004392: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer's disease
Cognition
Alpha-7 nAChR
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 348
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to Day 182 or Early Termination
Secondary outcomes:
measure: Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)
timeFrame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)
timeFrame: Baseline to Day 182 or Early Termination
measure: Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)
timeFrame: Baseline to Day 182 or Early Termination
measure: Caregiver perceived burden using the Zarit Burden Interview (ZBI)
timeFrame: Baseline to Day 182 or Early Termination
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Costa Mesa
country: United States
state: California
city: Culver City
country: United States
state: California
city: Encino
country: United States
state: California
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Orange
country: United States
state: California
city: Redding
country: United States
state: California
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Norwich
country: United States
state: Connecticut
city: Atlantis
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Park Ridge
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Newton
country: United States
state: Massachusetts
city: Plymouth
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: Hattiesburg
country: United States
state: Mississippi
city: Creve Coeur
country: United States
state: Missouri
city: Princeton
country: United States
state: New Jersey
city: Springfield
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Latham
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Norristown
country: United States
state: Pennsylvania
city: Plains
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Williamsburg
country: United States
state: Virginia
city: Richland
country: United States
state: Washington
city: Geelong
country: Australia
state: Victoria
city: Leuven
country: Belgium
city: Kelowna
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Chatham
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Praha
country: Czech Republic
city: Rychnov nad Kneznou
country: Czech Republic
city: Milano
country: Italy
state: Lombardia
city: Busan
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Bialystok
country: Poland
city: Warszawa
country: Poland
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: Kwa-Zulu Natal
city: Bellville
country: South Africa
state: Western Cape
city: George
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Terrassa
country: Spain
state: Barcelona
city: Burgos
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Glasgow
country: United Kingdom
city: Isleworth
country: United Kingdom
city: Northampton
country: United Kingdom
city: Penarth
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
References: