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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 10 mg EVP-0962 Orally administered once daily for 14 days |
|
| Arm 2 | Experimental | 50 mg EVP-0962 Orally administered once daily for 14 days |
|
| Arm 3 | Experimental | 100 mg EVP-0962 Orally administered once daily for 14 days |
|
| Arm 4 | Experimental | 200 mg EVP-0962 Orally administered once daily for 14 days |
|
| Arm 5 | Placebo Comparator | Placebo orally administered for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-0962 | Drug | Arms: 1,2,3,4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 0-36 hours post dose | |
| To measure the concentration of Amyloid Beta in cerebral spinal fluid | 0-36 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-36 hours post dose | |
| To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
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| Placebo |
| Drug |
Arm 5 |
|
| 0-36 hours post dose |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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