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WithdrawnPhase 1

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

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

Asset

Dabigatran

Listed sites

0

Recruiting sites

-

Enrollment

-

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

Alzheimer's diseaseAmyloid biomarker required (PET/CSF)MMSE ≥20

Primary endpoint

Evaluate dabigatran efficacy in MCI and mild AD population

Identifiers

Registered as

NCT IDNCT03752294
Org study IDRIN001-001

Timeline

Milestones

Study first posted2018-11-23actual
Study start2019-05estimated (month precision)
Primary completion2022-05estimated (month precision)
Study completion2022-05estimated (month precision)
Last update posted2025-04-17actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 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

2. English speaking men \& woman age 50 -85 years (inclusive)

3. Ability to provide informed consent

4. MMSE score >20 at screening

5. Informant or caregiver (e.g. family member, friend) willing to participate in semi-structured interviews

6. 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.

7. CDR Scale Global Score between 0.5 and 1

8. Stable dosing (prior 3-months) of standard AD medications are allowed

9. Demonstrated willingness to comply with study visit schedule, laboratory studies, and other study procedures

Exclusion criteria

1. Pre-menopausal women (last menstruation < 1 year prior to screening) who are not surgically sterile.

2. Creatinine clearance < 50mL/min

3. 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)

4. Cerebrovascular disease

5. Toxic, inflammatory, and metabolic disorders, all of which may require specific investigations

6. MRI Flair or T2 signal changes in the medial temporal lobe that are consistent with infectious or vascular insults

7. Sudden onset or early occurrence of the following symptoms: gait disturbances, seizures, major and prevalent behavioral changes

8. Inability to swallow pills

9. Current anticoagulant therapy

10. Conditions associated with an increased risk of bleeding (e.g. major surgery within 30-days of baseline, planned surgery or intervention during treatment period)

11. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding

12. Gastrointestinal hemorrhage within the past year

13. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30-days; hemorrhagic disorder or bleeding diathesis

14. 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)

15. Recent malignancy or radiation therapy (within 6-months) and a survival rate of 3-years,

16. Active infective endocarditis

17. 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)

18. Active hepatitis B (HBs antigen +, anti HBc IgM +), active hepatitis A

19. HIV/AIDS diagnosis

MRI exclusionary criteria

1. Brain Aneurysm Clip

2. Implanted neural stimulator

3. Implanted cardiac pacemaker or defibrillator

4. Cochlear implant

5. Ocular foreign body (e.g. metal shavings)

6. Other implanted medical devices: (e.g. Swan Ganz catheter, mechanical prosthetic heart)

7. Insulin pump

8. Metal shrapnel or bullet

Additional concomitant drug exclusionary criteria will be applied by investigator.

Endpoints (5)

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

Global cognition
3
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Global cognition

3 endpoints
Secondary/protocol endpoint

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

Time frame:12 - 24 months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:24-months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

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

Time frame:24-months

Montreal Cognitive Assessment (MoCA)

descriptive

Fluid / digital biomarkers

1 endpoint
Primary/protocol endpoint

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

categorical status, descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:21-months

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.