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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02004392
• Other study ID #: EVP-6124-026
• Secondary ID: 2013-002654-75
• Status: Terminated
• Phase: Phase 3
• First received: November 27, 2013
• Last updated: May 2, 2016
• Start date: June 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2015
• Source: FORUM Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthAustralia: National Health and Medical Research CouncilBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labor and WelfareMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Africa: Medicines Control CouncilSouth Korea: Ministry of Food and Drug SafetySpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationPortugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 348
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• EVP-6124

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FORUM Pharmaceuticals Inc

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  Italy,  Korea, Republic of,  Netherlands,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)		Baseline to Day 182 or Early Termination	No
Secondary	Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)		Baseline to Day 182 or Early Termination	No
Secondary	Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)		Baseline to Day 182 or Early Termination	No
Secondary	Caregiver perceived burden using the Zarit Burden Interview (ZBI)		Baseline to Day 182 or Early Termination	No