Alzheimer's Disease Education and Referral Center

Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil

Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil

Overall Status: 
Recruiting
Brief Description: 

Alzheimer's disease can affect the olfactory bulb and parts of the brain, resulting in difficulty with the sense of smell. Researchers will determine if this difficulty can predict the conversion to Alzheimer's disease in people with amnestic mild cognitive impairment (MCI) and track participants' response to therapy with the Alzheimer's drug donepezil.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
95 Years
Both
No
Inclusion Criteria: 
    • Amnestic mild cognitive impairment, with subjective memory complaints
    • Wechsler Memory Scale-R Logical Memory combined Story A + B immediate recall score or combined Story A + B delayed recall score; alternatively, Free and Cued Selective Reminding Test immediate recall or delayed recall score; alternatively, Selective Reminding Test immediate recall or delayed recall score, all greater than 1.5 standard deviations below norms
    • Mini Mental State (MMSE) score of at least 23; Clinical Dementia Rating (CDR) of 0.5
    • Availability of study partner
Exclusion Criteria: 
    • Dementia based on DSM-IV criteria or probable Alzheimer's disease based on NINCDS-ADRDA criteria
    • Schizophrenia, schizoaffective disorder, other psychosis, or bipolar disorder
    • Alcohol or substance dependence or abuse (current or within past 6 months)
    • Current untreated major depression or suicidality
    • Parkinson's disease, Lewy body disease, multiple sclerosis, central nervous system infection, Huntington's disease, amyotrophic lateral sclerosis, or other major neurological disorder
    • Mental retardation
    • Clinical stroke with residual neurological deficits
    • Acute, severe, unstable medical illness
    • Active cancer; history of successfully treated cancer is acceptable
    • Medical contraindication to donepezil treatment or prior history of intolerability to donepezil treatment
    • Prohibited medications: cholinesterase inhibitors (donepezil, rivastigmine, galantamine), memantine, medications with anticholinergic effects that have been shown to adversely impact cognition, benzodiazepines in lorazepam equivalents greater than or equal to 2 mg daily, narcotics
    • History of anosmia (loss of sense of smell) due to any cause
    • Head trauma with loss of consciousness; nasal sinus disease; current upper respiratory infection; severe allergies to odors; current smoker of more than 1 pack daily
Detailed Description: 

During this 1-year study, investigators will evaluate, treat, and follow 60 older adults with amnestic MCI, who will receive memory and olfactory assessments at weeks 8, 26, and 52. Atropine nasal spray will be administered for participants to take an odor detection and identification test, after which treatment with the Alzheimer's drug donepezil will start and continue for 52 weeks. Participants who cannot tolerate donepezil can take galantamine or rivastigmine, which are similar drugs. This project will help select people with MCI for treatment based on the ability of olfaction tests to predict response to donepezil and similar drugs.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Recruiting
Name: Jennifer Ferrar, B.S.
Phone: 646-774-7204
Email: ferrarj@nyspi.columbia.edu
Lead Sponsor: 
Agency
New York State Psychiatric Institute
Collaborator Sponsor: 
Agency
Department of Defense
Facility Investigators: 
NameRoleAffiliation
Davangere Devanand, MD
Principal Investigator
Columbia University
Gregory Pelton, MD
Study Director
Columbia University
Study Contact: 
NamePhoneEmail
Jennifer Ferrar
212-543-5176
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
Olfactory Deficits in Mild Cognitive Impairment as a Predictor of Improved Cognition on Donepezil
Study Start Date: 
August 2012
Study End Date: 
April 2015
Disease Stage: 
Early
Enrollment: 
60