- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01661673
Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease
January 10, 2014 updated by: FORUM Pharmaceuticals Inc
Safety, Tolerability, Pharmacokinetics, and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease
This study is being conducted to determine the safety, tolerability, pharmacokinetics, and effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early Alzheimer's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, sequential escalating repeat daily dose study conducted in two parts.
The first part is being conducted in healthy subjects and will evaluate safety, tolerability, and pharmacokinetics and pharmacodynamics of escalating EVP-0962 doses (10, 50 100 and 200 mg) or matching placebo following once-daily administration for 14 days.
The second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of EVP-0962 following once-daily administration for 14 days in patients with mild cognitive impairment or early Alzheimer's disease at the dose level selected based on the available safety, pharmacokinetics and pharmacodynamics observations in the first part.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Glendale, California, United States, 91206
- Glendale Adventist Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Part 1: Male and female subjects between the ages of 45 to 65 (inclusive) in good health with a BMI of 18-32 kg/m2 and negative urine drug screen of abuse test.
- Part 2: Male and female subjects between the ages of 45 to 85 (inclusive), MRI/CT scans compatible with diagnosis of MCI or early AD, meets the classification of MCI due to AD as defined by the National Institute on Aging-Alzheimer's Association, and a BMI of 18-32 kg/m2(inclusive). Subjects must meet the following Cognitive criteria: Subject Memory Complaint, cognitive impairment in one or more areas, CDR-SB score less than or equal 1.0, MMSE greater than 24, and no impairment in social or occupational functioning.
Exclusion Criteria:
- History of seizure disorder, symptomatic orthostatic hypotension, QTc values greater than 450 ms, positive drug screening tests
- Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
- C-SSRS suicidal ideation score of 4 or 5
- Unwilling to abstain from vigorous exercise
- Concurrent disease other than MCI or early AD that is attributing to patient's cognitive impairment.
- Lumbar spine X-rays show anatomic contraindications to lumbar puncture
- History of spinal surgery or chronic low back pain
- History of migraine headaches
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
10 mg EVP-0962 Orally administered once daily for 14 days
|
Arms: 1,2,3,4
|
EXPERIMENTAL: Arm 2
50 mg EVP-0962 Orally administered once daily for 14 days
|
Arms: 1,2,3,4
|
EXPERIMENTAL: Arm 3
100 mg EVP-0962 Orally administered once daily for 14 days
|
Arms: 1,2,3,4
|
EXPERIMENTAL: Arm 4
200 mg EVP-0962 Orally administered once daily for 14 days
|
Arms: 1,2,3,4
|
PLACEBO_COMPARATOR: Arm 5
Placebo orally administered for 14 days
|
Arm 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of adverse experiences reported by subjects and/or observed by investigator and repeated clinical evaluations of physical examinations, vital signs, 12-lead ECG (electrocardiogram), and lab tests (hematology, chemistry, urinalysis)
Time Frame: Screening (Day-45 to Day -1) through Day 23 (end of study visit)
|
Screening (Day-45 to Day -1) through Day 23 (end of study visit)
|
To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects
Time Frame: 0-36 hours post dose
|
0-36 hours post dose
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To measure the concentration of Amyloid Beta in cerebral spinal fluid
Time Frame: 0-36 hours post dose
|
0-36 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the rate of synthesis of Amyloid Beta and steady-state levels in the cerebral spinal fluid in MCI or early Alzheimer's disease patients
Time Frame: 0-36 hours post dose
|
0-36 hours post dose
|
To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma
Time Frame: 0-36 hours post dose
|
0-36 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
August 3, 2012
First Submitted That Met QC Criteria
August 6, 2012
First Posted (ESTIMATE)
August 9, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2014
Last Update Submitted That Met QC Criteria
January 10, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVP-0962-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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