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TerminatedPhase NAResults posted

Comparative Research of Alzheimer's Disease Drugs

Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs

Lead sponsor

Indiana University

Assets

Donepezil / Galantamine / Rivastigmine

Listed sites

Recruiting sites

Enrollment

200

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Discontinuation Rates

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 IDNCT01362686

Org study IDR01HS019818-01https://reporter.nih.gov/quickSearch/R01HS019818-01

AhrqR01HS019818-01

Timeline

Milestones

Study start2011-04 (month precision)

Study first posted2011-05-30estimated

Primary completion2015-10actual (month precision)

Study completion2015-10actual (month precision)

Last update posted2017-02-27actual

Results first posted2017-02-27actual

Assets

Drug assets

Donepezil Galantamine Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•older adults with a diagnosis of possible or probable Alzheimer's disease

•planning to initiate treatment with a cholinesterase inhibitor

•planning to continue care in the memory care practice

•participation by a family caregiver willing to complete the study outcome assessments

•access to a telephone

•ability to understand English-Language survey instruments

Exclusion criteria

• prior serious adverse event from the study medications

Endpoints (6)

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

Caregiver / quality of life

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 6, 12, 18 week interviews from enrollment

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 6, 12, 18 week interviews from enrollment

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), units on a scale	Standard deviation
Donepezil6 WeekNPI Patientn=59 Participants	12.71	17.10
6 Week NPI Caregivern=59 Participants	5.94	9.09
12 Week NPI Patientn=59 Participants	9.62	13.56
12 Week NPI Caregivern=59 Participants	5.66	7.34
18 Week NPI Patientn=59 Participants	9.06	13.87
18 Week NPI Caregivern=59 Participants	5.56	7.66
Galantamine6 WeekNPI Patientn=58 Participants	9.42	13.21
6 Week NPI Caregivern=58 Participants	4.40	5.80
12 Week NPI Patientn=58 Participants	8.40	13.27
12 Week NPI Caregivern=58 Participants	4.33	6.01
18 Week NPI Patientn=58 Participants	10.67	13.85
18 Week NPI Caregivern=58 Participants	6.22	7.56
Rivastigmine6 WeekNPI Patientn=54 Participants	8.63	11.73
6 Week NPI Caregivern=54 Participants	3.91	4.86
12 Week NPI Patientn=54 Participants	5.24	5.54
12 Week NPI Caregivern=54 Participants	2.22	2.86
18 Week NPI Patientn=54 Participants	7.26	7.36
18 Week NPI Caregivern=54 Participants	2.89	3.17

Caregiver / quality of life

4 endpoints

Primary/protocol endpoint

Discontinuation Rates

Time frame:6, 12, and 18 week interviews from enrollment

descriptive

Primary/registry result

Discontinuation Rates

Time frame:6, 12, and 18 week interviews from enrollment

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Donepeziln=67 Participants	26	-
Galantaminen=66 Participants	35	-
Rivastigminen=63 Participants	37	-

Secondary/protocol endpoint

Healthy Aging Brain Care (HABC)-Monitor

Time frame:baseline, 6, 12, and 18 week interviews

event count, event

Secondary/registry result

Healthy Aging Brain Care (HABC)-Monitor

Time frame:baseline, 6, 12, and 18 week interviews

event count, event

Posted result

Group	Value (mean), units on a scale	Standard deviation
DonepezilBaseline HABCn=59 Participants	18.76	13.64
6 Week HABCn=59 Participants	18.61	15.16
12 Week HABCn=59 Participants	16.04	13.41
18 Week HABCn=59 Participants	16.90	15.30
GalantamineBaseline HABCn=58 Participants	18.34	11.91
6 Week HABCn=58 Participants	19.16	12.72
12 Week HABCn=58 Participants	18.00	15.71
18 Week HABCn=58 Participants	19.92	14.28
RivastigmineBaseline HABCn=54 Participants	16.61	11.49
6 Week HABCn=54 Participants	16.43	10.52
12 Week HABCn=54 Participants	13.63	9.34
18 Week HABCn=54 Participants	15.80	9.01

Publications (7)

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

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.