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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02004392




Registration number
NCT02004392
Ethics application status
Date submitted
27/11/2013
Date registered
9/12/2013
Date last updated
3/05/2016

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2013-002654-75
Secondary ID [2] 0 0
EVP-6124-026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EVP-6124

Experimental: EVP-6124, low dose - low dose, Tablet, Once Daily, Day 1 through Day 182

Experimental: EVP-6124, high dose - high dose, Tablet, Once Daily, Day 1 through Day 182


Treatment: Drugs: EVP-6124


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [1] 0 0
Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)
Timepoint [1] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [2] 0 0
Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)
Timepoint [2] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [3] 0 0
Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)
Timepoint [3] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [4] 0 0
Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)
Timepoint [4] 0 0
Baseline to Day 182 or Early Termination
Secondary outcome [5] 0 0
Caregiver perceived burden using the Zarit Burden Interview (ZBI)
Timepoint [5] 0 0
Baseline to Day 182 or Early Termination

Eligibility
Key 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
Minimum age
55 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Geelong
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Louisiana
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Maine
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Massachusetts
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Mississippi
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Texas
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Utah
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Vermont
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Virginia
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Washington
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
State/province [30] 0 0
Ontario
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Czech Republic
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Praha
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Czech Republic
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Rychnov nad Kneznou
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Italy
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Lombardia
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Poland
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Bialystok
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Poland
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Warszawa
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South Africa
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Gauteng
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Kwa-Zulu Natal
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South Africa
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Western Cape
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Spain
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Barcelona
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Burgos
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Madrid
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Spain
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Salamanca
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Glasgow
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Isleworth
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Northampton
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Penarth
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
FORUM Pharmaceuticals Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02004392
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02004392