Status:
WITHDRAWN
A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.
Lead Sponsor:
University of Rhode Island
Collaborating Sponsors:
Alzheimer's Drug Discovery Foundation
Boehringer Ingelheim
Conditions:
Mild Cognitive Impairment
Mild Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03752294
Start Date
May 1 2019
End Date
May 1 2022
Last Update
April 17 2025
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