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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

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ClinicalTrials.gov Identifier: NCT01661673
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

Tracking Information
First Submitted Date  ICMJE August 3, 2012
First Posted Date  ICMJE August 9, 2012
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
  • 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) ]
  • To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects [ Time Frame: 0-36 hours post dose ]
  • To measure the concentration of Amyloid Beta in cerebral spinal fluid [ Time Frame: 0-36 hours post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
  • 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 ]
  • To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma [ Time Frame: 0-36 hours post dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer's Disease
Intervention  ICMJE
  • Drug: EVP-0962
    Arms: 1,2,3,4
  • Drug: Placebo
    Arm 5
Study Arms  ICMJE
  • Experimental: Arm 1
    10 mg EVP-0962 Orally administered once daily for 14 days
    Intervention: Drug: EVP-0962
  • Experimental: Arm 2
    50 mg EVP-0962 Orally administered once daily for 14 days
    Intervention: Drug: EVP-0962
  • Experimental: Arm 3
    100 mg EVP-0962 Orally administered once daily for 14 days
    Intervention: Drug: EVP-0962
  • Experimental: Arm 4
    200 mg EVP-0962 Orally administered once daily for 14 days
    Intervention: Drug: EVP-0962
  • Placebo Comparator: Arm 5
    Placebo orally administered for 14 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2012)
52
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01661673
Other Study ID Numbers  ICMJE EVP-0962-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FORUM Pharmaceuticals Inc
Study Sponsor  ICMJE FORUM Pharmaceuticals Inc
Collaborators  ICMJE Parexel
Investigators  ICMJE Not Provided
PRS Account FORUM Pharmaceuticals Inc
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP