NCT01661673

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

August 3, 2012

Last Update Submit

January 10, 2014

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • 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

    0-36 hours post dose

Study Arms (5)

Arm 1

EXPERIMENTAL

10 mg EVP-0962 Orally administered once daily for 14 days

Drug: EVP-0962

Arm 2

EXPERIMENTAL

50 mg EVP-0962 Orally administered once daily for 14 days

Drug: EVP-0962

Arm 3

EXPERIMENTAL

100 mg EVP-0962 Orally administered once daily for 14 days

Drug: EVP-0962

Arm 4

EXPERIMENTAL

200 mg EVP-0962 Orally administered once daily for 14 days

Drug: EVP-0962

Arm 5

PLACEBO COMPARATOR

Placebo orally administered for 14 days

Drug: Placebo

Interventions

EVP-0962DRUG

Arms: 1,2,3,4

Arm 1Arm 2Arm 3Arm 4
PlaceboDRUG

Arm 5

Arm 5

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 9, 2012

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

US(1)