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

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

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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 |
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

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
United States, California | |
Glendale Adventist Medical Center | |
Glendale, California, United States, 91206 |
Responsible Party: | FORUM Pharmaceuticals Inc |
ClinicalTrials.gov Identifier: | NCT01661673 |
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 |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |