NCT00257673

Brief Summary

The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

57 active sites

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

Study Start

First participant enrolled

November 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 6, 2008

Status Verified

May 1, 2008

Enrollment Period

1.9 years

First QC Date

November 22, 2005

Last Update Submit

May 5, 2008

Conditions

Alzheimer's Disease

Keywords

CognitionAlzheimer'sCognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Change from baseline at wk 12

Secondary Outcomes (1)

  • Other Cognitive Assessments, activities of daily living, functional assessments and safety

Study Arms (3)

A

EXPERIMENTAL

Active 30 mg MEM 1003

Drug: MEM 1003

B

EXPERIMENTAL

90 mg MEM 1003

Drug: MEM 1003

C

PLACEBO COMPARATOR

Placebo for MEM 1003

Drug: Placebo for MEM 1003

Interventions

MEM 1003DRUG

30 mg twice a day

A
Placebo for MEM 1003DRUG

Placebo twice a day

C

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • standardized MMSE Score of 10 to 24 points
  • diagnosis of probable Alzheimer's disease
  • magnetic resonance imaging or computed tomography examination compatible with AD
  • modified Hachinski Ischemia Score of less than or equal to 4
  • currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine

You may not qualify if:

  • head injury associated with cognitive impairment
  • history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
  • treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
  • treatment with calcium channel blockers or any investigational medications within the prior 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

Unknown Facility

Northport, Alabama, 35476, United States

Location

Unknown Facility

Mesa, Arizona, 85201, United States

Location

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Sun City, Arizona, 85351, United States

Location

Unknown Facility

El Centro, California, 92243, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

San Francisco, California, 94109, United States

Location

Unknown Facility

Torrence, California, 90505, United States

Location

Unknown Facility

Hamden, Connecticut, 06518, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Brooksville, Florida, 34613, United States

Location

Unknown Facility

Chiefland, Florida, 32626, United States

Location

Unknown Facility

Coral Springs, Florida, 33065, United States

Location

Unknown Facility

Deerfield Beach, Florida, 33064, United States

Location

Unknown Facility

Delray Beach, Florida, 33445, United States

Location

Unknown Facility

Hallandale, Florida, 33009, United States

Location

Unknown Facility

Hialeah, Florida, 33016, United States

Location

Unknown Facility

Miami, Florida, 33137, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Miami, Florida, 33173, United States

Location

Unknown Facility

Plantation, Florida, 33317, United States

Location

Unknown Facility

Port Charlotte, Florida, 33952, United States

Location

Unknown Facility

Sarasota, Florida, 34243, United States

Location

Unknown Facility

St. Petersburg, Florida, 33701, United States

Location

Unknown Facility

Sunrise, Florida, 33351, United States

Location

Unknown Facility

Tampa, Florida, 33609, United States

Location

Unknown Facility

Tampa, Florida, 33647, United States

Location

Unknown Facility

West Palm Beach, Florida, 33409, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Decatur, Georgia, 30030, United States

Location

Unknown Facility

Chicago, Illinois, 60610, United States

Location

Unknown Facility

New Orleans, Louisiana, 70114, United States

Location

Unknown Facility

Shreveport, Louisiana, 71104, United States

Location

Unknown Facility

Towson, Maryland, 21286, United States

Location

Unknown Facility

Fall River, Massachusetts, 02721, United States

Location

Unknown Facility

Saint Loius, Missouri, 63141, United States

Location

Unknown Facility

Berlin, New Jersey, 08009, United States

Location

Unknown Facility

Long Branch, New Jersey, 07740, United States

Location

Unknown Facility

Princeton, New Jersey, 08560, United States

Location

Unknown Facility

Ridgewood, New Jersey, 07450, United States

Location

Unknown Facility

Toms River, New Jersey, 08755, United States

Location

Unknown Facility

Albany, New York, 12208, United States

Location

Unknown Facility

Staten Island, New York, 10312, United States

Location

Unknown Facility

Morganton, North Carolina, 28655, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Colmar, Pennsylvania, 18915, United States

Location

Unknown Facility

Media, Pennsylvania, 19063, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19149, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

Johnson City, Tennessee, 37601, United States

Location

Unknown Facility

Bedford, Texas, 76021, United States

Location

Unknown Facility

Bulverde, Texas, 78163, United States

Location

Unknown Facility

San Antonio, Texas, 78217, United States

Location

Unknown Facility

Midvale, Utah, 84047, United States

Location

Unknown Facility

Bennington, Vermont, 05201, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Stephen Murray, MD, PhD

    Memory Pharmaceutical Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

US(57)