Status:
COMPLETED
Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
United States Department of Defense
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-95 years
Phase:
PHASE4
Brief Summary
Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal lobe (entorhin...
Detailed Description
In this clinical trial, the investigators will evaluate, treat and follow a broad sample of 60 adult patients with amnestic MCI at New York State Psychiatric Institute/Columbia University Medical Cent...
Eligibility Criteria
Inclusion
- Of either sex, age 55-95 years old
- Patients who meet criteria for amnestic mild cognitive impairment by meeting all of the following:
- (i) subjective memory complaints (ii) Wechsler Memory Scale-R Logical Memory combined Story A + B immediate recall score or combined Story A + B delayed recall score or Free and Cued Selective Reminding Test immediate recall or delayed recall score greater than 1.5 Standard Deviation (SD) below norms or Selective Reminding Test immediate recall or delayed recall score greater than 1.5 SD below norms iii) no functional impairment consistent with dementia
- Folstein Mini Mental State (MMSE) score ≥ 23 out of 30
- Clinical Dementia Rating (CDR) of 0.5 (questionable dementia)
- Availability of informant
Exclusion
- Meets Criteria for dementia by Diagnostic and Statistical Manual IV (DSM-IV) criteria or probable Alzheimer's disease
- Meets DSM IV criteria for:
- (i)schizophrenia, schizoaffective disorder, other psychosis, or bipolar I disorder (ii)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, other major neurological disorder.
- Mental Retardation
- Clinical stroke with residual neurological deficits. MRI findings of cerebrovascular disease (small infarcts, lacunes, periventricular disease) in the absence of clinical stroke with residual neurological deficits will not lead to exclusion.
- Patients receiving cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine will be excluded.
- Acute, severe, unstable medical illness. For cancer, patients with active illness or metastases will be excluded, but past history of successfully treated cancer will not lead to exclusion.
- Medical contraindication to donepezil treatment or prior history of intolerability to donepezil treatment.
- Medications with anticholinergic effects that have been shown to adversely impact cognition will not be permitted. Benzodiazepines in lorazepam equivalents greater than or equal to 2 mg daily and narcotics will also not be permitted.
- Exclusion criterion for olfaction: history of anosmia due to any cause (e.g. traumatic or congenital) verified by UPSIT score of \<11 out of 40; head trauma with loss of consciousness; nasal sinus disease, current upper respiratory infection; severe allergies to odors; current smoker \> 1 pack daily.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01845636
Start Date
August 1 2012
End Date
March 1 2016
Last Update
July 9 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
New York State Psychiatric Institute
New York, New York, United States, 10032