CAF

CompletedPhase 4Results posted

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)

Lead sponsor

Intermountain Health Care, Inc.

Assets

Dabigatran / Warfarin

Listed sites

Recruiting sites

Enrollment

101

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥65

Primary endpoints

•Incident Dementia•ADAS-Cog

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 ID1050164

NCT IDNCT03061006

Timeline

Milestones

Study first posted2017-02-23actual

Study start2017-03-30actual

Primary completion2021-03-15actual

Study completion2021-03-15actual

Last update posted2026-05-12actual

Results first posted2026-05-12actual

Assets

Drug assets

Dabigatran Warfarin

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female >65 years of age.

2. Non-valvular atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 12 months of enrollment.

3. Moderate risk of thromboembolism based upon a CHADS score or CHADS2 Vasc score of ≥2.

4. Ability to complete a mini-mental status evaluation.

5. Ability to independently comprehend and complete a quality of life and dementia questionnaires.

6. Ability to provide informed consent for study participation.

7. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion criteria

1. Inability to take an anticoagulant due to known or perceived bleeding risk.

2. Known coagulopathy that may impact the choice, duration, efficacy and safety of anticoagulation therapy.

3. Atrial Fibrillation in the setting of valvular heart disease. Valvular heart disease defined as any surgical valve, mitral stenosis, or moderate-severe valvular heart disease.

4. Severe renal dysfunction, defined as a creatinine clearance rate <15 mL/min (documented within the last 3 months).

5. History of any form of dementia.

6. A life expectancy less than 24 months.

7. Inability to comply with the follow-up schedule.

8. Current participation in a clinical investigation that includes an active pharmacologic treatment arm.

9. An upper age limit not to be used if participation inclusion criteria are met.

10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.

11. Other conditions that in the opinion of the Principal Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.

12. Concurrent pharmacologic treatment that is required to treat a condition long-term in which concurrent use of dabigatran etexilate is contraindicated.

13. Treatment with any anticoagulant drug for stroke prevention for more than 30 days.

-Aspirin and P2Y12 inhibitors (e.g. clopidogrel (Plavix), or prasugrel (Effient)) are not considered anticoagulant drugs.

-If the subject has received any anticoagulant drug for stroke prevention for less than 30 days, the Principal Investigator(s) or a Co-Investigator will decide whether or not the subject is eligible for this study

14. The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.

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

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Number of Participants With Moderate Decline in Cognitive Function Based on Results of the Alzheimer's Disease Assessment Scale and the Disability Assessment for Dementia.

Time frame:24 months

ADAS-Cog

change from baseline, improvement

Primary/registry result

Number of Participants With Moderate Decline in Cognitive Function Based on Results of the Alzheimer's Disease Assessment Scale and the Disability Assessment for Dementia.

Time frame:24 months

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Dabigatran Etexilaten=32 Participants	5	-
Warfarinn=31 Participants	2	-

p0.23Chi-squared

Secondary/protocol endpoint

Percent Change From Baseline in Mini-Mental State Examination Scores.

Time frame:24 months

Mini-Mental State Examination (MMSE)

percent change from baseline, improvement

Secondary/registry result

Percent Change From Baseline in Mini-Mental State Examination Scores.

Time frame:24 months

Mini-Mental State Examination (MMSE)

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	Standard deviation
Dabigatran Etexilaten=32 Participants	4.3	8.9
Warfarinn=31 Participants	2.6	8.3

p0.56Wilcoxon (Mann-Whitney)

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist

Time frame:24 months

event count, event

Primary/registry result/low confidence

Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist

Time frame:24 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Dabigatran Etexilaten=32 Participants	0	-
Warfarinn=31 Participants	0	-

Secondary/protocol endpoint/low confidence

Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed

Time frame:24 months

event count, event

Secondary/protocol endpoint/low confidence

Changes From Baseline Scores on the Hachinski Ischemic Scale

Time frame:24 months

percent change from baseline, improvement

Secondary/registry result/low confidence

Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed

Time frame:24 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Dabigatran Etexilaten=32 Participants	2	-
Warfarinn=31 Participants	0	-

p0.24Fisher Exact

Secondary/registry result/low confidence

Changes From Baseline Scores on the Hachinski Ischemic Scale

Time frame:24 months

percent change from baseline, improvement

Posted result

Group	Value (mean), percentage of score change	Standard deviation
Dabigatran Etexilaten=32 Participants	7.3	46.9
Warfarinn=31 Participants	5.9	27.4

p0.50Wilcoxon (Mann-Whitney)

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

Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.
PMID35833913via 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.