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NCT Number: NCT01661673

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 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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVP-0962

Drug

Arms: 1,2,3,4

Placebo

Drug

Arm 5

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

FORUM Pharmaceuticals Inc

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
First posted
Aug 9, 2012
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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