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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01661673

Run by

FORUM Pharmaceuticals Inc

People needed

52

Starts

2012-11-01

Last updated by the study team

2014-01-13

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Glendale Adventist Medical Center — Glendale, California, United States

Full record on ClinicalTrials.gov

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