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CompletedPhase 4Results posted

Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil

Olfactory Deficits in Mild Cognitive Impairment as a Predictor of Improved Cognition on Donepezil

Lead sponsor

New York State Psychiatric Institute

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE ≥23

Primary endpoint

•Selective Reminding Test (SRT)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID6577

NCT IDNCT01845636

Other grantW81XWH-12-0142DOD and TATRC

Timeline

Milestones

Study start2012-08 (month precision)

Study first posted2013-05-03estimated

Primary completion2016-03actual (month precision)

Study completion2016-03actual (month precision)

Results first posted2018-03-13actual

Last update posted2018-07-09actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Global cognition

Function / daily living

Caregiver / quality of life

Global cognition

2 endpoints

Secondary/protocol endpoint

Total Number of Errors Measured Using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Time frame:Week 0, Week 8, Week 26, Week 52

ADAS-Cog

event count, event

Secondary/registry result

Total Number of Errors Measured Using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Time frame:Week 0, Week 8, Week 26, Week 52

ADAS-Cog

event count, event

Posted result

Group	Value (mean), Errors	Standard deviation
Donepezil Treatment & Atropine ChallengeWeek 0n=37 Participants	10.67	4.15
Week 8n=37 Participants	10.27	3.83
Week 26n=37 Participants	8.80	3.69
Week 52n=37 Participants	10.09	4.68

Memory

4 endpoints

Primary/protocol endpoint

Selective Reminding Test (SRT)

Time frame:Week 0, Week 8, Week 26, Week 52

event count, event

Primary/registry result

Selective Reminding Test (SRT)

Time frame:Week 0, Week 8, Week 26, Week 52

event count, event

Posted result

Group	Value (mean), Words	Standard deviation
Donepezil Treatment & Atropine ChallengeWeek 0n=37 Participants	33.61	8.15
Week 8n=37 Participants	36.23	9.27
Week 26n=37 Participants	36.81	9.22
Week 52n=37 Participants	37.13	10.59

Secondary/protocol endpoint

Measurement of Everyday Cognition (Ecog)

Time frame:Week 0, Week 4, Week 8, Week 26, Week 52

descriptive

Secondary/registry result

Measurement of Everyday Cognition (Ecog)

Time frame:Week 0, Week 4, Week 8, Week 26, Week 52

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Donepezil Treatment & Atropine ChallengeWeek 0n=37 Participants	60.27	23.13
Week 8n=37 Participants	62.80	27.91
Week 26n=37 Participants	63.37	28.93
Week 52n=37 Participants	65.39	29.53

Function / daily living

2 endpoints

Secondary/protocol endpoint

Pfeffer Functional Activities Questionnaire (FAQ)

Time frame:Week 0, Week 4, Week 8, Week 26, Week 52

descriptive

Secondary/registry result

Pfeffer Functional Activities Questionnaire (FAQ)

Time frame:Week 0, Week 4, Week 8, Week 26, Week 52

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Donepezil Treatment & Atropine ChallengeWeek 0n=37 Participants	3.73	4.17
Week 8n=37 Participants	4.37	4.72
Week 26n=37 Participants	4.40	4.74
Week 52n=37 Participants	5.16	5.36

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-plus)

Time frame:Week 8, Week 26, Week 52

descriptive

Secondary/registry result

Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-plus)

Time frame:Week 8, Week 26, Week 52

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Donepezil Treatment & Atropine ChallengeWeek 8n=37 Participants	3.43	0.7
Week 26n=37 Participants	3.31	0.74
Week 52n=37 Participants	3.13	1.18

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.