Senolytic Therapy to Modulate Progression of Alzheimer's Disease (SToMP-AD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04063124|
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Dasatinib + Quercetin||Phase 1 Phase 2|
Up to 40 potential candidates will be pre-screened to identify eligible men and women ages 65 years and over with a clinical diagnosis of early AD on a stable dose of cholinesterase inhibitors for at least 3 months (for example, Aricept).
Eligible participants will undergo laboratory assessments of blood and urine, receive study medications over a twelve week period, and complete pre- and post-treatment testing including: an MRI for digital imaging of the brain; lumbar puncture to obtain cerebrospinal fluid; memory and thinking assessments; quality of life questionnaires; and tests of walking, balance and strength, all of which will be done for research purposes only.
Participants must be accompanied by a Legally Authorized Representative and have no travel plans for 4-5 months that would interfere with study visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is an open-label pilot study of intermittent D+Q to measure its target engagement in CSF and blood, and to establish the feasibility and safety of D+Q treatment in older adults with early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Investigate the Safety and Feasibility of Senolytic Therapy to Modulate Progression of Alzheimer's Disease (SToMP-AD)|
|Actual Study Start Date :||February 14, 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: Intermittent D+Q
Senolytic treatment in 5 individuals with early AD to determine levels of drug that reach the central nervous system (CNS) by collecting cerebral spinal fluid (CSF), and begin collecting initial data on target engagement of senescent cells, AD-related markers, and AD-relevant outcomes for future trials.
Drug: Dasatinib + Quercetin
Intermittent D+Q administered for 2 days on/14 days off for 12 weeks (6 cycles)
Other Name: D+Q
- Brain penetrance of Dasatinib (D) [ Time Frame: Change from 0 to 12 weeks ]Cerebrospinal Fluid (CSF) collected by lumbar puncture before and after 12 weeks of treatment to determine levels of drug that reach the central nervous system will be measured by high performance liquid chromatography/mass spectrometry (HPLC/MS)
- Brain penetrance of Quercetin (Q) [ Time Frame: Change from 0 to 12 weeks ]CSF collected by lumbar puncture before and after 12 weeks of treatment to determine levels of drug that reach the central nervous system using HPLC/MS
- Alzheimer's Disease marker - CSF tau [ Time Frame: Change from 0 to 12 weeks ]Cerebrospinal Fluid collected by lumbar puncture analyzed for level of tau proteins present in CSF
- Alzheimer's Disease marker - CSF amyloid beta [ Time Frame: Change from 0 to 12 weeks ]Cerebrospinal Fluid collected by lumbar puncture analyzed for level of amyloid beta proteins present in CSF
- Senescence marker IL-6 in CSF [ Time Frame: Change from 0 to 12 weeks ]Laboratory measure of level of IL-6 found in CSF collected pre and post treatment
- Senescence marker P16 in CSF [ Time Frame: Change from 0 to 12 weeks ]Laboratory measure of level of P16 found in CSF collected pre and post treatment
- Electronic gait mapping under single and dual-task conditions [ Time Frame: Change from 0 to 12 weeks ]Participants walk on a pressure-sensitive walkway to capture data on gait speed
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Change from 0 to 12 weeks ]A test which scores the participant with score ranges between 0 and 30. A score of 26 or over is considered normal. Individuals with mild cognitive impairment score lower and individuals with Alzheimer's disease score even lower.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063124
|Contact: Nicolas Musi, MDemail@example.com|
|Contact: Amy R Sakladfirstname.lastname@example.org|
|United States, Texas|
|Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Nicolas Musi, MD. 210-617-5300 ext 15197 Musi@uthscsa.edu|
|Contact: Lauri Che Kelly, RN 210-617-5300 ext 13898 email@example.com|
|Principal Investigator: Nicolas Musi, MD|
|Principal Investigator:||Nicolas Musi, MD||UT Health San Antonio|