NCT00454870

Brief Summary

The purpose of this study is to determine in an 8-week treatment study if MEM 3454 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
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

7 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

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
6 months 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

8 months

First QC Date

March 30, 2007

Last Update Submit

May 5, 2008

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseaseCognitionCognitive impairment

Interventions

MEM 3454DRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable or possible Alzheimer's disease
  • MMSE score between 16 and 26 points
  • Modified Hachinski Ischemia Score of less than or equal to 4
  • Capable of performing cognitive tests and other procedures specified in protocol

You may not qualify if:

  • Head trauma associated with cognitive impairment
  • Evidence of significant neurological disease other than AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, CNS tumor, progressive supranuclear palsy, seizure disorder, etc.
  • Received AChE inhibitor therapy (e.g., rivastigmine, tacrine or galantamine) or NDMA-receptor antagonist, memantine, within 30 days or donepezil within 40 days of randomization
  • Received any investigational drug within 2 months of randomization or treatment with other nicotinic receptor agonists within 3 months of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Glendale, California, 91206, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Wichita, Kansas, 67207, United States

Location

Unknown Facility

Wichita, Kansas, 67211, United States

Location

Unknown Facility

Willingboro, New Jersey, 08046, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19139, 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 R Murray, MD, PhD

    Memory Pharmaceuticals Corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 2, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

US(7)