Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 16 for:    evp-6124

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004392
Recruitment Status : Terminated (Study has been suspended due to clinical hold.)
First Posted : December 9, 2013
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Drug: EVP-6124 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVP-6124, low dose
low dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Experimental: EVP-6124, high dose
high dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124



Primary Outcome Measures :
  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 [ Time Frame: Baseline to Day 182 or Early Termination ]
    Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS.


Secondary Outcome Measures :
  1. Change from Baseline in cognition using the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to Day 182 or Early Termination ]
  2. Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline to Day 182 or Early Termination ]
  3. Change from Baseline in quality of life using the EuroQol-5D (EQ-5D) [ Time Frame: Baseline to Day 182 or Early Termination ]
  4. Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3) [ Time Frame: Baseline to Day 182 or Early Termination ]
  5. Caregiver perceived burden using the Zarit Burden Interview (ZBI) [ Time Frame: Baseline to Day 182 or Early Termination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004392


  Show 86 Study Locations
Sponsors and Collaborators
FORUM Pharmaceuticals Inc

Layout table for additonal information
Responsible Party: FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02004392     History of Changes
Other Study ID Numbers: EVP-6124-026
2013-002654-75 ( EudraCT Number )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: September 2015
Keywords provided by FORUM Pharmaceuticals Inc:
Alzheimer's disease
Cognition
Alpha-7 nAChR
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders