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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661673
First Posted: August 9, 2012
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parexel
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc
August 3, 2012
August 9, 2012
January 13, 2014
November 2012
October 2013   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01661673 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • Drug: EVP-0962
    Arms: 1,2,3,4
  • Drug: Placebo
    Arm 5
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01661673
EVP-0962-002
No
Not Provided
Not Provided
FORUM Pharmaceuticals Inc
FORUM Pharmaceuticals Inc
Parexel
Not Provided
FORUM Pharmaceuticals Inc
January 2014

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