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:

Collaborator:

Parexel

Information provided by (Responsible Party):

FORUM Pharmaceuticals Inc

ClinicalTrials.gov Identifier:

NCT01661673

First received: August 3, 2012

Last updated: January 10, 2014

Last verified: January 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	August 3, 2012
Last Updated Date	January 10, 2014
Start Date ^ICMJE	November 2012
Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 6, 2012)	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) ] [ Designated as safety issue: Yes ] To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ] To measure the concentration of Amyloid Beta in cerebral spinal fluid [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
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 (submitted: August 6, 2012)	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 ] [ Designated as safety issue: No ] To determine single-and repeat-dose EVP-0962 pharmacokinetics in cerebral spinal fluid and plasma [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Arm (s)	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	52
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
Gender	Both
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	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	FORUM Pharmaceuticals Inc
Study Sponsor ^ICMJE	FORUM Pharmaceuticals Inc
Collaborators ^ICMJE	Parexel
Investigators ^ICMJE	Not Provided
Information Provided By	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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