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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease, Dementia

Intervention / Treatment
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* Drug: EVP-6124


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVP-6124, low dose<br>low dose, Tablet, Once Daily, Day 1 through Day 182 | Drug: EVP-6124<br> <br> |
| Experimental: EVP-6124, high dose<br>high dose, Tablet, Once Daily, Day 1 through Day 182 | Drug: EVP-6124<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Cognition, Alpha-7 nAChR