Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD) Study (NCT04685590) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD) Study
United States, Spain48 participantsStarted 2021-12-22
Plain-language summary
The objective of the study is to determine the safety, feasibility, and efficacy of senolytics in older adults with amnestic mild cognitive impairment (MCI) or early-stage AD (Clinical Dementia Rating (CDR)=0.5 or 1) who are tau PET positive
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ages 60 years and older at study entry
✓. Both sexes
✓. All ethnicities
✓. Diagnosis of amnestic mild cognitive impairment (aMCI) or early Alzheimer's disease (AD)
✓. Elevated tau protein as determined by CSF performed during screening. Evidence of elevated tau from previously available CSF samples will also be allowed for eligibility determination.
✓. FDA-approved medications for AD (e.g. donepezil, rivastigmine, galantamine) are permitted as long as the participant has been maintained on a stable dose for at least three months prior to study entry.
✓. Labs: Normal blood cell counts, normal liver and renal function without clinically significant excursions as determined by coordinating center Medical Monitor. Total cholesterol \<240 mg/dl, HbA1c ≤ 7%.
✓. Prothrombin Time (PT)/Partial Thromboplastin Time (PTT)/International Normalized Ratio (INR) within normal limits.
Exclusion criteria
✕. Body mass index (BMI)\>40 kg/m2.
✕. Average QTcF (from 3 ECGs obtained at least one minute apart) at screening of ≥450msec in males and ≥460msec in females.
✕. MRI contraindications including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
✕
What they're measuring
1
Serious Adverse Events (SAEs) and Adverse Events (AEs) in treatment group as compared to placebo group
✕. Any significant neurologic disease other than prodromal or early AD including Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
✕. Current or history of alcohol or substance abuse or dependence within the past 2 years per Diagnostic and Statistical Manual of Mental Disorders (DSM V criteria).
✕. Endorsement of current suicidality or suicidal ideation on the screening C-SSRS.
✕. Uncontrolled diabetes (HbA1c \> 7% or the current use of insulin or sulfonylureas).