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Mild Cognitive ImpairmentPhase 1NCT03752294

A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.

A Phase 1 study testing Dabigatran in people with Mild Cognitive Impairment and Mild Alzheimer's Disease, run by University of Rhode Island.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A randomized-control, double-blind, multi-center, delayed-start, pilot trial evaluating the disease modifying effects of a 150mg once-a-day dose vs. placebo of dabigatran in men and women, between the ages of 50-85 years, confirmed with MCI probably due to AD and mild Alzheimer's Disease. Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
Dabigatran
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
May 2019to May 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of MCI likely due to AD or mild AD based on IWG-2 criteria for typical AD (A plus B at any stage) 2011 revised criteria
  • English speaking men \& woman age 50 -85 years (inclusive)
  • Ability to provide informed consent
  • MMSE score >20 at screening
  • Informant or caregiver (e.g. family member, friend) willing to participate in semi-structured interviews
  • CSF Aβ positive (MCI and AD) or a positive amyloid positron emission tomography (PET) scan within 6-months prior to screening using IWG-2 criteria.
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  • CDR Scale Global Score between 0.5 and 1
  • Stable dosing (prior 3-months) of standard AD medications are allowed
  • Demonstrated willingness to comply with study visit schedule, laboratory studies, and other study procedures

Who cannot join

  • Pre-menopausal women (last menstruation < 1 year prior to screening) who are not surgically sterile.
  • Creatinine clearance < 50mL/min
  • Current psychiatric or neurological disorder that would contribute to cognitive impairment (focal neurological features early extrapyramidal signs, early hallucinations, cognitive fluctuations, non-AD dementia, major depression)
  • Cerebrovascular disease
  • Toxic, inflammatory, and metabolic disorders, all of which may require specific investigations
  • MRI Flair or T2 signal changes in the medial temporal lobe that are consistent with infectious or vascular insults
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  • Sudden onset or early occurrence of the following symptoms: gait disturbances, seizures, major and prevalent behavioral changes
  • Inability to swallow pills
  • Current anticoagulant therapy
  • Conditions associated with an increased risk of bleeding (e.g. major surgery within 30-days of baseline, planned surgery or intervention during treatment period)
  • History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
  • Gastrointestinal hemorrhage within the past year
  • Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30-days; hemorrhagic disorder or bleeding diathesis
  • Need for anticoagulant treatment of disorders, fibrinolytic agents within 48-hours of study baseline, uncontrolled hypertension (systolic blood pressure greater than 180mm Hg and/or diastolic blood pressure greater than 100 mm Hg)
  • Recent malignancy or radiation therapy (within 6-months) and a survival rate of 3-years,
  • Active infective endocarditis
  • Active liver disease (including but not limited to persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range; active hepatitis C (positive HCV RNA)
  • Active hepatitis B (HBs antigen +, anti HBc IgM +), active hepatitis A
  • HIV/AIDS diagnosis
  • MRI exclusionary criteria
  • Brain Aneurysm Clip
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g. metal shavings)
  • Other implanted medical devices: (e.g. Swan Ganz catheter, mechanical prosthetic heart)
  • Insulin pump
  • Metal shrapnel or bullet
  • Additional concomitant drug exclusionary criteria will be applied by investigator.

About this study

Official title: A 24-month, Randomized-control, Double-blind, Multi-center, Delayed-start, Pilot Study Evaluating Thrombin Inhibitions Alzheimer's Disease Using 150mg Dabigatran Daily: A Novel Therapeutic Target for Alzheimer's Disease

A randomized-control, double-blind, multi-center, delayed-start, pilot trial evaluating the disease modifying effects of a 150mg once-a-day dose vs. placebo of dabigatran in men and women, between the ages of 50-85 years, confirmed with MCI probably due to AD and mild Alzheimer's Disease.

Read the detailed description

The study will be conducted in 2-phases. The Phase I double-blind portion of the study consists of 40-60 active participants with MCI probably due to AD and mild AD randomized to 150mg once-a-day dose of dabigatran or placebo. A futility analysis will be conducted based on month 3 plasma biomarker changes from baseline. Excluding futility, at the end of Phase I, the study continues onto the open-label phase of the study where the placebo arm will be treated with 150mg once-a-day with dabigatran from months 10-21. The active treatment arm will continue on dabigatran through month-21. For final analysis, a difference in intercept of a generalized growth model between randomization groups during Phase 2 in the Cognitive Dementia Rating Scale-Sum of Boxes (CDR-SB) will be taken as evidence of effectiveness and justify further study. All patients will discontinue dabigatran after month 21 and a 3-month follow-up period will confirm whether or not the proposed cognitive effects can be sustained in the absence of treatment. The relationships between changes in levels of plasma biomarkers over time will be tested with regards to each other and relative to MRI and cognitive testing performed at scheduled intervals.

Being tested
Dabigatran, Placebo - Cap
Keywords
MCI, Mild AD, Dabigatran
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    Also called Pradaxa

    At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up.

  • Placebo - CapDrug

    Also called Study Drug

    At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up

Study groups in NCT03752294
Study groupRoleWhat they receive
DabigatranActive comparatorParticipants will receive 150mg dabigatran daily for a total of 9-months.
Receives: Drug: Dabigatran
PlaceboPlacebo comparatorParticipants will receive placebo daily for a total of 9-months.
Receives: Drug: Placebo - Cap
Open LabelActive comparatorAll study participants are assigned to receive 150mg dabigatran daily for a total of 12 months (study month 9 through month 21)
Receives: Drug: Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate dabigatran efficacy in MCI and mild AD population using changes in targeted plasma and CSF biomarker levels at 9 and 21 months

    Evaluate effectiveness of dabigatran (150mg daily) on disease modification measured by changes in targeted plasma and CSF biomarkers associated with the early stages of Alzheimer's disease

    Measured: 9 and 21-months

Secondary outcomes (4)

  1. Demonstrate a reduction in decline of cognitive function related to physical functioning in placebo arm after crossing over to 12-months of active treatment

    Demonstrate an observed benefit of cognitive performance/function using the ADCS ADL MCI

    Measured: 12 - 24 months

  2. Changes in cognitive performance in placebo arm after cross-over to open-label treatment phase

    Evaluate effectiveness of dabigatran (150mg daily) using the CDR-SB

    Measured: 24-months

  3. Safety and tolerability of dabigatran in experimental population (MCI and mild AD populations) based on reported serious and adverse events

    Determine the safety and tolerability of dabigatran in MCI probably due to AD and mild AD population using physician and patient reported adverse events.

    Measured: 21-months

  4. Evaluation of cognitive performance in placebo arm after cross-over to open-label treatment phase

    Evaluate effectiveness of dabigatran (150mg daily) using the MoCA

    Measured: 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study startMay 2019 (estimated)
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Why it stopped: Investigator left institution

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized-control, Double-blind, Multicenter, Delayed-start, Pilot
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03752294
Sponsor's protocol ID
RIN001-001
Status last verified
Apr 2025
First submitted
15 May 2018
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran in people with Mild Cognitive Impairment and Mild Alzheimer's Disease, run by University of Rhode Island.

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 9 inclusion and 29 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: withdrawn, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Evaluate dabigatran efficacy in MCI and mild AD population using changes in targeted plasma and CSF biomarker levels at 9 and 21 months (time frame: 9 and 21-months). 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 NCT03752294.

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 17 Apr 2025.

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