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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
Lead sponsor
Asset
Dabigatran
Listed sites
0
Recruiting sites
-
Enrollment
-
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•MMSE ≥20
Primary endpoint
•Evaluate dabigatran efficacy in MCI and mild AD population
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsDemonstrate 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
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
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 endpointEvaluate 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 endpointSafety 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 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.