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 has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01661673

First Posted: August 9, 2012

Last Update Posted: January 13, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Parexel

Information provided by (Responsible Party):

FORUM Pharmaceuticals Inc

Tracking Information

First Submitted Date ^ICMJE

August 3, 2012

First Posted Date ^ICMJE

August 9, 2012

Last Update Posted Date

January 13, 2014

Start Date ^ICMJE

November 2012

Primary Completion Date

October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01661673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Mild Cognitive Impairment
Alzheimer's Disease

Intervention ^ICMJE

Drug: EVP-0962
Arms: 1,2,3,4
Drug: Placebo
Arm 5

Study Arms

Experimental: Arm 1
10 mg EVP-0962 Orally administered once daily for 14 days

Intervention: Drug: EVP-0962
Experimental: Arm 2
50 mg EVP-0962 Orally administered once daily for 14 days

Intervention: Drug: EVP-0962
Experimental: Arm 3
100 mg EVP-0962 Orally administered once daily for 14 days

Intervention: Drug: EVP-0962
Experimental: Arm 4
200 mg EVP-0962 Orally administered once daily for 14 days

Intervention: Drug: EVP-0962
Placebo Comparator: Arm 5
Placebo orally administered for 14 days

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

45 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01661673

Other Study ID Numbers ^ICMJE

EVP-0962-002

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

FORUM Pharmaceuticals Inc

Study Sponsor ^ICMJE

FORUM Pharmaceuticals Inc

Collaborators ^ICMJE

Parexel

Investigators ^ICMJE

Not Provided

PRS Account

FORUM Pharmaceuticals Inc

Verification Date

January 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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