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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

Primary Purpose

Alzheimer's Disease, Dementia

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

EVP-6124

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Cognition, Alpha-7 nAChR

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EVP-6124, low dose

EVP-6124, high dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

Caregiver perceived burden using the Zarit Burden Interview (ZBI)

Full Information

NCT ID

NCT02004392

First Posted

November 27, 2013

Last Updated

May 2, 2016

Sponsor

FORUM Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT02004392

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Terminated

Why Stopped

Study has been suspended due to clinical hold.

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FORUM Pharmaceuticals Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Dementia

Keywords

Alzheimer's disease, Cognition, Alpha-7 nAChR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

348 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVP-6124, low dose

Arm Type

Experimental

Arm Description

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

Arm Title

EVP-6124, high dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

EVP-6124

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame