← Trials/Trial dossier/NCT03073876

CompletedPhase 4Results posted

Detecting an Early Response to Donepezil With Measures of Visual Attention

Lead sponsor

NYU Langone Health

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥15

Primary endpoints

•Foreperiod Effect Task - Processing Speed•Covert Orienting Task•Attentional Blink Task Baseline

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

NCT IDNCT03073876

Org study IDWUH 05030

Timeline

Milestones

Study start2005-12-01actual

Primary completion2009-07-31actual

Study first posted2017-03-08actual

Results first posted2019-11-05actual

Study completion2021-01-13actual

Last update posted2021-02-04actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of Alzheimer's Disease

•Mini Mental State Examination score >15 / 30

•Can swallow pills

Exclusion criteria

•No other dementia due to Parkinson's disease, Lewy Body dementia, Normal Pressure Hydrocephalus, Fronto-temporal dementia, or prominent cerebral vascular accident

•No prior or concurrent use of cholinesterase inhibitors

•No prior or concurrent use of memantine hydrochloride

•No other concurrent anticholinergic treatments

Endpoints (40)

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

Executive function / language

Global cognition

Other (unclassified)

Memory

Function / daily living

Behavior / neuropsychiatric

Global cognition

8 endpoints

Primary/protocol endpoint

Change of ADAS-COG From Baseline to 6 Months

Time frame:Baseline to 6 months

ADAS-Cog

descriptive

Primary/registry result

Change of ADAS-COG From Baseline to 6 Months

Time frame:Baseline to 6 months

ADAS-Cog

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drug Treatmentn=23 Participants	-.29	4.70

Secondary/protocol endpoint

Change in Dementia Rating Scale

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mini Mental Status Examination

Time frame:Baseline to 6 weeks

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Time frame:Baseline to 6 weeks

ADAS-Cog

descriptive

Secondary/registry result

Change in Dementia Rating Scale

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drugn=12 Participants	1.67	6.91
Placebon=11 Participants	-.54	6.27

Secondary/registry result

Mini Mental Status Examination

Time frame:Baseline to 6 weeks

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drugn=12 Participants	-.17	2.44
Placebon=10 Participants	-1.09	2.02

Secondary/registry result

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Time frame:Baseline to 6 weeks

ADAS-Cog

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drugn=12 Participants	-1.90	4.92
Placebon=10 Participants	.99	2.25

Memory

2 endpoints

Secondary/protocol endpoint

Change in Hopkins Verbal Learning Test- Revised - Recall

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/registry result

Change in Hopkins Verbal Learning Test- Revised - Recall

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drugn=12 Participants	.17	1.8
Placebon=10 Participants	.40	4.79

Executive function / language

20 endpoints

Primary/protocol endpoint

Change in Foreperiod Effect Task - Processing Speed

Time frame:Baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Covert Orienting Task

Time frame:Baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Attentional Blink Task Baseline to 6 Weeks - Stimulus Onset Asynchrony (SOA) 266ms

Time frame:Baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Attentional Blink Task Baseline to 6 Weeks - SOA 399ms

Time frame:Baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)

Time frame:6 weeks

descriptive

Primary/protocol endpoint

Change in Foreperiod Effect Task - Variability (350ms & 500ms)

Time frame:Baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Covert Orienting at 6 Weeks - Fatigue Across Blocks

Time frame:6 weeks

time to event, event

Primary/registry result

Change in Foreperiod Effect Task - Processing Speed

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (median), response time in msec	Standard deviation
Drug350n=12 Participants	42	176.3
500n=12 Participants	33	176.7
Placebo350n=11 Participants	13	9
500n=11 Participants	13	9

Primary/registry result

Change in Covert Orienting Task

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (median), milliseconds	Reported bounds
Drugn=11 Participants	496.5	-414.6 - 578.4
Placebon=12 Participants	452.5	-401.7 - 503.3

Primary/registry result

Change in Attentional Blink Task Baseline to 6 Weeks - Stimulus Onset Asynchrony (SOA) 266ms

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), milliseconds	Standard deviation
Drug Treatmentn=23 Participants	-.06	.32

Primary/registry result

Change in Attentional Blink Task Baseline to 6 Weeks - SOA 399ms

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), milliseconds	Standard deviation
Drug Treatmentn=23 Participants	-.022	.33

Primary/registry result

Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)

Time frame:6 weeks

descriptive

Posted result

Group	Value (median), msec	Standard deviation
DrugBlock 1n=12 Participants	400	87.4
Block 2n=12 Participants	395	85.3
PlaceboBlock 1n=11 Participants	331	200.7
Block 2n=11 Participants	385	254.2

Primary/registry result

Change in Foreperiod Effect Task - Variability (350ms & 500ms)

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), msec	Standard deviation
Drug350msn=12 Participants	-26.7	42.97
500msn=12 Participants	28.46	110.63
Placebo350msn=10 Participants	-4.5	34.44
500msn=10 Participants	8.37	39.73

Primary/registry result

Covert Orienting at 6 Weeks - Fatigue Across Blocks

Time frame:6 weeks

time to event, event

Posted result

Group	Value (median), msec	Standard deviation
DrugBlock 1n=12 Participants	415	145.1
Block 5n=12 Participants	451	134.2
PlaceboBlock 1n=11 Participants	402	95.1
Block 5n=11 Participants	487	144.3

Secondary/protocol endpoint

Change in Language Function Assessed With the Letter Fluency Test

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change on Trail Making Test - Condition

Time frame:Baseline to 6 weeks

descriptive

Secondary/protocol endpoint

Change in Category Fluency Test

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/registry result

Change in Language Function Assessed With the Letter Fluency Test

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drugn=12 Participants	.003	1.51
Placebon=9 Participants	.17	2.52

Secondary/registry result

Change on Trail Making Test - Condition

Time frame:Baseline to 6 weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drugn=12 Participants	-1.67	39.45
Placebon=10 Participants	-2.3	41.46

Secondary/registry result

Change in Category Fluency Test

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drugn=12 Participants	.17	5.56
Placebon=10 Participants	-2.8	4.02

Function / daily living

2 endpoints

Primary/protocol endpoint

Instrumental Activities of Daily Living

Time frame:6 months

descriptive

Primary/registry result

Instrumental Activities of Daily Living

Time frame:6 months

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drug Treatmentn=23 Participants	6.54	4.23

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Neuropsychiatric Inventory Score

Time frame:6 months

Neuropsychiatric Inventory (NPI)

event count, event

Primary/registry result

Neuropsychiatric Inventory Score

Time frame:6 months

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drug Treatmentn=23 Participants	14.09	14.26

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Change in Digit Span Forward

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Visual Form Discrimination

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Digit Span Backwards

Time frame:Baseline to 6 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Change in Digit Span Forward

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drugn=12 Participants	-0.6	1
Placebon=10 Participants	-0.4	0.75

Secondary/registry result/low confidence

Change in Visual Form Discrimination

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Drugn=12 Participants	.92	3.09
Placebon=11 Participants	.33	3.94

Secondary/registry result/low confidence

Change in Digit Span Backwards

Time frame:Baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Drugn=12 Participants	0.5	0.8
Placebon=10 Participants	0.1	0.75

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Vila-Castelar C, Ly JJ, Kaplan L, Van Dyk K, Berger JT, Macina LO, Stewart JL, Foldi NS. Attention Measures of Accuracy, Variability, and Fatigue Detect Early Response to Donepezil in Alzheimer's Disease: A Randomized, Double-blind, Placebo-Controlled Pilot Trial. Arch Clin Neuropsychol. 2019 May 1;34(3):277-289. doi: 10.1093/arclin/acy032.
PMID29635383via DERIVED

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.