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 is currently recruiting participants.
Verified April 2013 by EnVivo Pharmaceuticals, Inc.
Sponsor:
EnVivo Pharmaceuticals, Inc.
Collaborator:
Parexel
Information provided by (Responsible Party):
EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01661673
First received: August 3, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Mild Cognitive Impairment Alzheimer's Disease |
Drug: EVP-0962 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by EnVivo Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
- To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
- To measure the concentration of Amyloid Beta in cerebral spinal fluid [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661673
Contacts
| Contact: Mollie Barrett | (818) 254-1679 | mollie.barrett@parexel.com |
Locations
| United States, California | |
| Glendale Adventist Medical Center | Recruiting |
| Glendale, California, United States, 91206 | |
| Principal Investigator: David Han, M.D. | |
Sponsors and Collaborators
EnVivo Pharmaceuticals, Inc.
Parexel
More Information
No publications provided
| Responsible Party: | EnVivo Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01661673 History of Changes |
| Other Study ID Numbers: | EVP-0962-002 |
| Study First Received: | August 3, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013