NCT00000174

Brief Summary

This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico. Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

15 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

First Submitted

Initial submission to the registry

October 29, 1999

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 1999

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2000

First QC Date

October 29, 1999

Last Update Submit

June 23, 2005

Conditions

Alzheimer DiseaseCognition Disorders

Keywords

Mild cognitive impairmentAlzheimer's diseaseMemoryCholinergic agentsCholinesterase inhibitors

Interventions

RivastigmineDRUG

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor.
  • Are male or female without child-bearing potential (i.e., surgically sterilized \[via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy\], at least one year postmenopausal, or using adequate birth control).
  • Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study.
  • Will provide written informed consent prior to their participation in the study.
  • Show evidence of mild cognitive impairment (MCI) by meeting all of the following criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1.
  • Have a friend or family member who is willing to participate in the study as an informant. The informant must see the subject at least once a week for several hours and be available to accompany the subject to the screening and baseline visits, and at a minimum, be accessible by telephone for other scheduled visits.

You may not qualify if:

  • Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk.
  • Cognitive impairment sufficient to warrant a diagnosis of dementia.
  • Met the DSM-IV and NINCDS-ADRDA criteria for AD.
  • A clinical diagnosis of AD.
  • A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible after appropriate treatment of the depressive episode. A minimum of four weeks washout of antidepressant medication should occur prior to screening. Subjects with a prior history of depression (but not currently depressed) are allowed in the study.
  • Fewer than four years of formal education.
  • A documented history of transient ischemic attacks.
  • Baseline MRI findings or CT-scan findings within a year of screening that are consistent with a process other than AD, e.g., stroke, tumor, brain trauma or hydrocephalus, that may contribute to the subject's MCI. Lacunae infarcts present in areas affecting cognition (entorhinal cortex, hippocampus, medial temporal lobe) will also exclude the subject from the study.
  • A score of greater than 4 on the Modified Hachinski Ischemic Scale.
  • A current diagnosis of any primary neurodegenerative disorder, e.g., Parkinson's disease.
  • A current diagnosis of uncontrolled seizure disorder.
  • A current diagnosis of active peptic ulceration.
  • A current diagnosis of severe and unstable cardiovascular disease.
  • A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, second or third degree atrio-ventricular block).
  • A current diagnosis of acute, severe, or unstable asthmatic conditions.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Medici Research Centers

Peoria, Arizona, 85381, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80220, United States

Location

Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)

Fort Lauderdale, Florida, 33321, United States

Location

Miami Research Associates

Miami, Florida, 33176, United States

Location

Center for Clinical Trials and Research

Venice, Florida, 34285, United States

Location

Indiana University Alzheimer's Center

Indianapolis, Indiana, 46202, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Alzheimer's Research Corporation

Lakewood, New Jersey, 08701, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Pahl Brain Associates, P.C.

Oklahoma City, Oklahoma, 73118, United States

Location

Clinical Studies, Ltd., Philadelphia

Philadelphia, Pennsylvania, 19106, United States

Location

St. Paul Medical Center

Dallas, Texas, 75235, United States

Location

University of Washington, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Feldman HH, Ferris S, Winblad B, Sfikas N, Mancione L, He Y, Tekin S, Burns A, Cummings J, del Ser T, Inzitari D, Orgogozo JM, Sauer H, Scheltens P, Scarpini E, Herrmann N, Farlow M, Potkin S, Charles HC, Fox NC, Lane R. Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx study. Lancet Neurol. 2007 Jun;6(6):501-12. doi: 10.1016/S1474-4422(07)70109-6.

    PMID: 17509485DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognition DisordersCognitive Dysfunction

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Steven Ferris, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 1999

First Posted

November 1, 1999

Last Updated

June 24, 2005

Record last verified: 2000-01

Locations

US(15)