DementiaPhase 4CAFNCT03061006
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation
A Phase 4 study testing Dabigatran Etexilate and Warfarin in people with Dementia and Cognition Disorders, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Cognition Disorders, Cerebral Ischemic Events
- What is being tested?
- Dabigatran Etexilate and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 15 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female >65 years of age.
- Non-valvular atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 12 months of enrollment.
- Moderate risk of thromboembolism based upon a CHADS score or CHADS2 Vasc score of ≥2.
- Ability to complete a mini-mental status evaluation.
- Ability to independently comprehend and complete a quality of life and dementia questionnaires.
- Ability to provide informed consent for study participation.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Who cannot join
- Inability to take an anticoagulant due to known or perceived bleeding risk.
- Known coagulopathy that may impact the choice, duration, efficacy and safety of anticoagulation therapy.
- 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.
- Severe renal dysfunction, defined as a creatinine clearance rate <15 mL/min (documented within the last 3 months).
- History of any form of dementia.
- A life expectancy less than 24 months.
Show all 16Show fewer
- Inability to comply with the follow-up schedule.
- Current participation in a clinical investigation that includes an active pharmacologic treatment arm.
- An upper age limit not to be used if participation inclusion criteria are met.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- 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.
- Concurrent pharmacologic treatment that is required to treat a condition long-term in which concurrent use of dabigatran etexilate is contraindicated.
- 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
- The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)
Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. After written informed consent is obtained, subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1: Dabigatran etexilate (150 mg BID if CrCL > 30 mL/min, or 75 mg BID if CrCL > 15 to 30 mL/min or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney function every 6 months will be done for Group 1. Standard warfarin follow-up and education, based upon system criteria, will be done for Group 2. All subjects will be followed for 24 months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months post-anticoagulation visits as well as other visits deem necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit following the week 1 visit, except at the 3-month visit when only one questionnaire will be administered. To determine brain volume and characteristic changes representative of micro-bleeding, the first 10 subjects in each treatment group who are willing and able to undergo the procedure will participate in a MRI sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on this sub-group.
- Conditions
- Dementia, Cognition Disorders, Cerebral Ischemic Events
- Being tested
- Dabigatran Etexilate, Warfarin
- Medical subject headings
- Dementia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran EtexilateDrug
Also called Pradaxa
150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL > 15 to 30 mL/min); Assessment of kidney function every 6 months.
WarfarinDrug
Also called Coumadin
Dose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria.
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran Etexilate | Experimental | 150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL 15-30 mL/min) Receives: Drug: Dabigatran Etexilate |
| Warfarin | Active comparator | Dose-adjusted warfarin (INR: 2.0-3.0) Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist
Incident dementia will be determined by a formal diagnosis of dementia by a neurologist
Measured: 24 months
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.
Determined by measuring the change from baseline to study conclusion on the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog11, with scores ranging from 0 to 70, and higher scores indicating greater impairment) and the Disability Assessment for Dementia (DAD, with scores ranging from 0 to 100, and higher scores indicating less impairment). An increase in ADAS-cog11 of >30% is considered significant for moderate cognitive decline. In subjects that score <50% on the DAD, there is a direct correlation with global deterioration scales and scores. Subjects with a 30% decrease in DAD score or those with a score <50% will be considered to have moderate cognitive decline. These scores will be aggregated and if a patient meets either one of the cognitive decline definitions they will be deemed positive for cognitive impairment.
Measured: 24 months
Secondary outcomes (3)
Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed
Measured: 24 months
Percent Change From Baseline in Mini-Mental State Examination Scores.
The Mini-Mental State Examination (MMSE) is commonly used to measure cognitive change over time. Scores on the MMSE range from 0 to 30. Any score of 24 or more indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. We measured the percent change from baseline scores.
Measured: 24 months
Changes From Baseline Scores on the Hachinski Ischemic Scale
The Hachinski Ischemic Scale (HIS) is commonly used clinical tool to differentiate between different types of dementia. Scores on the HIS range from 0 to 18. A score of less than 4 suggests primary dementia. A score of 4-7 is indeterminate. A score more than 7 suggests vascular dementia. We measured percentage change from baseline scores on the HIS.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start30 Mar 2017
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061006
- Sponsor's protocol ID
- 1050164
- Acronym
- CAF
- Status last verified
- Nov 2022
- First submitted
- 9 Feb 2017
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35833913
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)
- ClinicalTrials.gov ID
- NCT03061006
- Acronym / sponsor ID
- CAF / 1050164
- Conditions
- Dementia, Cognition Disorders, Cerebral Ischemic Events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. After written informed consent is obtained, subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1: Dabigatran etexilate (150 mg BID if CrCL > 30 mL/min, or 75 mg BID if CrCL > 15 to 30 mL/min or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney function every 6 months will be done for Group 1. Standard warfarin follow-up and education, based upon system criteria, will be done for Group 2. All subjects will be followed for 24 months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months post-anticoagulation visits as well as other visits deem necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit following the week 1 visit, except at the 3-month visit when only one questionnaire will be administered. To determine brain volume and characteristic changes representative of micro-bleeding, the first 10 subjects in each treatment group who are willing and able to undergo the procedure will participate in a MRI sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on this sub-group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran Etexilate | Experimental | Drug: Dabigatran Etexilate150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL 15-30 mL/min) |
| Warfarin | Active comparator | Drug: WarfarinDose-adjusted warfarin (INR: 2.0-3.0) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Male or female >65 years of age.
- Non-valvular atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 12 months of enrollment.
- Moderate risk of thromboembolism based upon a CHADS score or CHADS2 Vasc score of ≥2.
- Ability to complete a mini-mental status evaluation.
- Ability to independently comprehend and complete a quality of life and dementia questionnaires.
Key exclusion criteria (16 listed)
- Inability to take an anticoagulant due to known or perceived bleeding risk.
- Known coagulopathy that may impact the choice, duration, efficacy and safety of anticoagulation therapy.
- 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.
- Severe renal dysfunction, defined as a creatinine clearance rate <15 mL/min (documented within the last 3 months).
- History of any form of dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran EtexilateAlso: Pradaxa150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL > 15 to 30 mL/min); Assessment of kidney function every 6 months. | Drug | Dabigatran Etexilate |
| WarfarinAlso: CoumadinDose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria. | Drug | Warfarin |
Primary outcome
Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist
Time frame: 24 months
Incident dementia will be determined by a formal diagnosis of dementia by a neurologist
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
Determined by measuring the change from baseline to study conclusion on the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog11, with scores ranging from 0 to 70, and higher scores indicating greater impairment) and the Disability Assessment for Dementia (DAD, with scores ranging from 0 to 100, and higher scores indicating less impairment). An increase in ADAS-cog11 of >30% is considered significant for moderate cognitive decline. In subjects that score <50% on the DAD, there is a direct correlation with global deterioration scales and scores. Subjects with a 30% decrease in DAD score or those with a score <50% will be considered to have moderate cognitive decline. These scores will be aggregated and if a patient meets either one of the cognitive decline definitions they will be deemed positive for cognitive impairment.
3 secondary outcomes
Number of Participants With Stroke or Transient Ischemic Attack (TIA) or Intracranial Bleed
Time frame: 24 months
Percent Change From Baseline in Mini-Mental State Examination Scores.
Time frame: 24 months
Changes From Baseline Scores on the Hachinski Ischemic Scale
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35833913Kwan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran Etexilate and Warfarin in people with Dementia and Cognition Disorders, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Incident Dementia Determined by a Formal Diagnosis of Dementia by a Neurologist (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.