Start:
August 2012
End:
March 2016
Enrollment:
60
What Is This Study About?
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.
Do I Qualify To Participate in This Study?
Must have:
- 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
Must NOT have:
- 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
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Collaborator Sponsor
Source:
ClinicalTrials.gov ID:
NCT01845636