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

NCT02004392 | Terminated Phase 3 DMC

• 2 other identifiers: EVP-6124-0262013-002654-75
• Study Type: interventional
• Target: 348
• Locations: 12 countries
• Sites: 86

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.

Conditions

Alzheimer's Disease; Dementia

Keywords

Alzheimer's disease; Cognition; Alpha-7 nAChR

Outcome Measures

Primary Outcomes (1)

• 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

  Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS.

  Baseline to Day 182 or Early Termination

Secondary Outcomes (5)

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

  Baseline to Day 182 or Early Termination

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

  Baseline to Day 182 or Early Termination

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

  Baseline to Day 182 or Early Termination

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

  Baseline to Day 182 or Early Termination

• Caregiver perceived burden using the Zarit Burden Interview (ZBI)

  Baseline to Day 182 or Early Termination

Study Arms (2)

EVP-6124, low dose

EXPERIMENTAL

low dose, Tablet, Once Daily, Day 1 through Day 182

Drug: EVP-6124

EVP-6124, high dose

EXPERIMENTAL

high dose, Tablet, Once Daily, Day 1 through Day 182

Drug: EVP-6124

Interventions

EVP-6124 DRUG

EVP-6124, high dose; EVP-6124, low dose

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc: lead

Study Sites (86)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Culver City, California, United States

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Encino, California, United States

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Glendale, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Orange, California, United States

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Redding, California, United States

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San Diego, California, United States

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New Haven, Connecticut, United States

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Norwich, Connecticut, United States

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Atlantis, Florida, United States

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Brooksville, Florida, United States

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Delray Beach, Florida, United States

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Fort Myers, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Sunrise, Florida, United States

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West Palm Beach, Florida, United States

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Columbus, Georgia, United States

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Park Ridge, Illinois, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Bangor, Maine, United States

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Newton, Massachusetts, United States

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Plymouth, Massachusetts, United States

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Flowood, Mississippi, United States

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Hattiesburg, Mississippi, United States

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Creve Coeur, Missouri, United States

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Princeton, New Jersey, United States

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Springfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Latham, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Wilmington, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Norristown, Pennsylvania, United States

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Plains, Pennsylvania, United States

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East Providence, Rhode Island, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Bennington, Vermont, United States

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Charlottesville, Virginia, United States

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Williamsburg, Virginia, United States

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Richland, Washington, United States

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Geelong, Victoria, Australia

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Leuven, Belgium

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Kelowna, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Chatham, Ontario, Canada

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Toronto, Ontario, Canada

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Prague, Czechia

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Rychnov nad Kněžnou, Czechia

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Milan, Lombardy, Italy

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Amsterdam, Netherlands

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Bialystok, Poland

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Warsaw, Poland

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Bellville, Western Cape, South Africa

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George, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Busan, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Terrassa, Barcelona, Spain

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Burgos, Spain

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Madrid, Spain

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Salamanca, Spain

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Glasgow, United Kingdom

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Isleworth, United Kingdom

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Northampton, United Kingdom

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Penarth, United Kingdom

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Southampton, United Kingdom

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MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 9, 2013
• Study Start: June 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 3, 2016

Record last verified: 2015-09

Locations

NL (1); US (56); BE (1); ES (4); GB (5); PL (2); ZA (6); CA (4); KR (3); IT (1); AU (1); CZ (2)