Trial Outcomes & Findings for Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly (NCT NCT02874924)

NCT ID: NCT02874924

Last Updated: 2018-12-04

Results Overview

T cell function measured by number of T cells per millimeter cubed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Rapamycin Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Overall Study STARTED	14	14	6
Overall Study COMPLETED	11	14	6
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Rapamycin Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Overall Study Adverse Event	2	0	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapamycin n=14 Participants Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo n=14 Participants Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects n=6 Participants No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group	Total n=34 Participants Total of all reporting groups
Age, Customized Age, 70 years and older	14 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	14 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	34 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: In the cardiovascular arm, no T cell function was analyzed.

T cell function measured by number of T cells per millimeter cubed.

Outcome measures

Outcome measures
Measure	Rapamycin n=11 Participants Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo n=14 Participants Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Immunological Responses	8.33 cells/mm^3 Standard Deviation 3.82	11.24 cells/mm^3 Standard Deviation 4.45	—

SECONDARY outcome

Timeframe: 8 weeks

Population: Walking speed was not analyzed in the cardiovascular group.

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.

Outcome measures

Outcome measures
Measure	Rapamycin n=11 Participants Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo n=14 Participants Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Physical Performance	7.75 Seconds Standard Deviation 1.12	7.17 Seconds Standard Deviation 1.12	—

SECONDARY outcome

Timeframe: 8 weeks

Population: EXIT25 was not collected or analyzed in cardiovascular group.

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.

Outcome measures

Outcome measures
Measure	Rapamycin n=14 Participants Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo n=14 Participants Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Cognitive Function	7.2 score on a scale Standard Deviation 4.52	6.92 score on a scale Standard Deviation 4.23	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Due to technical problems with equipment, data were not captured for analysis.

Pulse Wave Velocity is measured using an Electrocardiogram (ECG)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Cardiovascular effects were not measured in the Rapamycin versus placebo group, only open label rapamycin group.

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.

Outcome measures

Outcome measures
Measure	Rapamycin Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects n=6 Participants No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
Volume of Diastolic Filling	—	—	132.84 milliliters Standard Deviation 26.82

Adverse Events

Rapamycin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapamycin Alone - Cardiovascular Effects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rapamycin n=14 participants at risk Rapamycin 1mg taken once daily for 8 weeks Rapamycin: treatment	Placebo n=14 participants at risk Placebo taken once daily for 8 weeks Placebo: control	Rapamycin Alone - Cardiovascular Effects n=6 participants at risk No placebo control; Rapamycin 1mg once daily for 8 weeks Rapamycin: No placebo control in this substudy group
General disorders Rash of face	7.1% 1/14 • Number of events 1 • 8 weeks per subject	0.00% 0/14 • 8 weeks per subject	0.00% 0/6 • 8 weeks per subject
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • 8 weeks per subject	0.00% 0/14 • 8 weeks per subject	0.00% 0/6 • 8 weeks per subject

Additional Information

Dean L. Kellogg, Jr, MD, PhD

Univ TX Health Science Center San Antonio

Phone: 2106175197

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place