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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Drug: EVP-0962 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : November 2012
Actual Primary Completion Date : October 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
10 mg EVP-0962 Orally administered once daily for 14 days
 Drug: EVP-0962
Arms: 1,2,3,4
Experimental: Arm 2
50 mg EVP-0962 Orally administered once daily for 14 days
 Drug: EVP-0962
Arms: 1,2,3,4
Experimental: Arm 3
100 mg EVP-0962 Orally administered once daily for 14 days
 Drug: EVP-0962
Arms: 1,2,3,4
Experimental: Arm 4
200 mg EVP-0962 Orally administered once daily for 14 days
 Drug: EVP-0962
Arms: 1,2,3,4
Placebo Comparator: Arm 5
Placebo orally administered for 14 days
 Drug: Placebo
Arm 5


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects [ Time Frame: 0-36 hours post dose ]
  3. To measure the concentration of Amyloid Beta in cerebral spinal fluid [ Time Frame: 0-36 hours post dose ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma [ Time Frame: 0-36 hours post dose ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661673


Locations
United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Sponsors and Collaborators
FORUM Pharmaceuticals Inc
Parexel
More Information
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Responsible Party: FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01661673     History of Changes
Other Study ID Numbers: EVP-0962-002
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders