Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly
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|ClinicalTrials.gov Identifier: NCT02874924|
Recruitment Status : Completed
First Posted : August 22, 2016
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging||Drug: Rapamycin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Mammalian Target of Rapamycin Inhibition and Other Metabolism Modulating Interventions on the Elderly: Immune, Cognitive, and Functional Consequences|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Rapamycin 1mg taken once daily for 8 weeks
Other Name: Sirolimus
Placebo Comparator: Placebo
Placebo taken once daily for 8 weeks
Experimental: Rapamycin Alone - Cardiovascular Effects
No placebo control; Rapamycin 1mg once daily for 8 weeks
No placebo control in this substudy group
Other Name: Sirolimus
- Immunological Responses [ Time Frame: 8 weeks ]T cell function measured by number of T cells per millimeter cubed.
- Physical Performance [ Time Frame: 8 weeks ]walking speed: Timed 40-foot walk: each participant will perform 3 walks (timed with a stopwatch) at their preferred walking speed over a measured 40-foot path. Results will be averaged for analysis. The faster the walking speed the better the performance.
- Cognitive Function [ Time Frame: 8 weeks ]
The Executive Interview (EXIT25) - This test is a brief bedside test that consists of 25 items measuring abilities that include:
Executive functioning, Motor sequencing, Spoken alternate sequencing, Verbal fluency, Design fluency, Persistence, Resistance to interference, Reflexes Scoring directions are listed under each of the 25 portions of this test. For each section, the client is given a score of a 0, 1, or 2. A score "0" indicates no impairment, a score of "1" indicates some impairment, and a score of "2" indicates severe impairment. Directions for what qualifies as each score are listed under each section. The points are totaled and criteria are given for severe, moderate, and no impairment. Minimum score is -0- and maximum is 50. A score of 15 or below indicates normal executive functioning, a score of above 15 indicates moderate to severe impairment.
- Cardiovascular Effect [ Time Frame: 8 weeks ]Pulse Wave Velocity is measured using an Electrocardiogram (ECG)
- Volume of Diastolic Filling [ Time Frame: 8 weeks ]Diastolic function was assessed using Magnetic Resonance Imaging (MRI) of the heart to measure the diastolic filling of the heart in participants in the open label rapamycin group.
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): NCT02874924
|United States, Texas|
|San Antonio, Texas, United States, 78220|
|Principal Investigator:||Dean Kellogg, MD PhD||University of Texas|