NCT00062972

Brief Summary

People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer's disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 1999

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2003

Completed
Last Updated

April 25, 2017

Status Verified

May 1, 2011

First QC Date

June 18, 2003

Last Update Submit

April 21, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCognitive DysfunctionTreatment InterventionsVerbal memory deficits

Interventions

donepezilDRUG
glucoseDRUG

Eligibility Criteria

Age18 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • MS as defined by the Poser criteria
  • Expanded Disability Status Scale (EDSS) score of 0 to 6.5
  • Stable neurologic function for at least 30 days prior to study entry
  • Agree to continue all current medications for study duration
  • Rey Auditory Verbal Learning Test score in low normal range or below
  • Mini-mental status exam score of 26 or higher
  • Montgomery-Asberg Depression Scale scaled score of 14 or lower
  • Fluent in English

You may not qualify if:

  • Use of anticholinergic or benzodiazepine medication
  • Change in dosage of medications judged to have the potential to impact cognitive function (e.g., antispasticity medications) within 2 weeks of study entry
  • Current alcohol or substance abuse
  • History of neurological or major medical problem that has a known effect on cognitive functioning
  • History of noncompliance
  • Visual or upper extremity impairment which precludes ability to participate in cognitive assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital and Medical Center

Stony Brook, New York, 11794-8121, United States

Location

Related Publications (5)

  • Prosiegel M, Michael C. Neuropsychology and multiple sclerosis: diagnostic and rehabilitative approaches. J Neurol Sci. 1993 Apr;115 Suppl:S51-4. doi: 10.1016/0022-510x(93)90209-h.

    PMID: 8340793BACKGROUND

  • Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Clinical outcomes assessment in multiple sclerosis. Ann Neurol. 1996 Sep;40(3):469-79. doi: 10.1002/ana.410400321.

    PMID: 8797541BACKGROUND

  • Wild KV, Lezak MD,Whitman RH, Bourdette DN: Psychosocial impact of cognitive impairment in the multiple sclerosis patient. J Clin Exp Neuropsychology 415: 685-691, 1991

    BACKGROUND

  • Krupp LB, Sliwinski M, Masur DM, Friedberg F, Coyle PK. Cognitive functioning and depression in patients with chronic fatigue syndrome and multiple sclerosis. Arch Neurol. 1994 Jul;51(7):705-10. doi: 10.1001/archneur.1994.00540190089021.

    PMID: 8018045BACKGROUND

  • Kujala P, Portin R, Revonsuo A, Ruutiainen J. Attention related performance in two cognitively different subgroups of patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 1995 Jul;59(1):77-82. doi: 10.1136/jnnp.59.1.77.

    PMID: 7608714BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisCognitive Dysfunction

Interventions

DonepezilGlucose

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Lauren B. Krupp, MD

    Department of Neurology, University Hospital Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 18, 2003

First Posted

June 19, 2003

Study Start

September 1, 1999

Study Completion

August 1, 2002

Last Updated

April 25, 2017

Record last verified: 2011-05

Locations

US(1)