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mTOR inhibitor

Rapamune for Cognitive Impairment (CARPE_DIEM Trial)

Phase < 1
Waitlist Available
Led By Mitzi Gonzales, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights

CARPE_DIEM Trial Summary

This trial will evaluate if Rapamune can penetrate the central nervous system and if it is safe and tolerable for older adults with MCI or early AD.

Who is the study for?
This trial is for older adults with Mild Cognitive Impairment or early Alzheimer's Disease who have stable blood cell counts and are on a steady dose of AD medications. Participants need an authorized representative for consent and must be available for all study visits. Exclusions include diabetes, poor wound healing, substance abuse, certain medication use, recent cancer treatments, liver or lung disease, heart failure, pregnancy, recent severe cardiovascular events.Check my eligibility
What is being tested?
The trial tests the effects of Rapamune (RAPA) on cognition in patients with cognitive impairment due to MCI or early Alzheimer's. It aims to assess how well RAPA enters the brain and its safety and impact on cognition and daily functioning as initial proof-of-concept.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Rapamune may include mouth sores, diarrhea, increased risk of infection due to immune system suppression; it can also affect blood pressure and kidney function.

CARPE_DIEM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Brain Barrier Penetration of RAPA
Secondary outcome measures
Adverse Events
Benson Figure Copy
Change in CSF A Beta-42 Levels From Baseline to 8 Weeks
+5 more

Side effects data

From 2014 Phase 1 & 2 trial • 30 Patients • NCT00286156
60%
Nonserious infections
60%
Oral ulcerations
40%
Miscellaneous/other
30%
Gastrointestinal symptoms
10%
Decrease visual acuity
10%
Edema
10%
nephrotic range proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Rapamycin Dose (STD)
Low Dose Rapamycin (LD)
Standard Care

CARPE_DIEM Trial Design

1Treatment groups
Experimental Treatment
Group I: RAPA interventionExperimental Treatment1 Intervention
Sirolimus 1mg orally once a day for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapamune
2020
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
316 Previous Clinical Trials
390,643 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
450 Previous Clinical Trials
87,251 Total Patients Enrolled
Mitzi Gonzales, PhDPrincipal InvestigatorUT Health San Antonio

Media Library

Rapamune (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04200911 — Phase < 1
Alzheimer's Disease Research Study Groups: RAPA intervention
Alzheimer's Disease Clinical Trial 2023: Rapamune Highlights & Side Effects. Trial Name: NCT04200911 — Phase < 1
Rapamune (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200911 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there precedents of Rapamune use in prior research studies?

"Presently, there are 125 active Rapamune trials with 13 at Phase 3. Despite the majority of studies being administered in Cincinnati, Ohio, this medication is accessible through 1074 medical facilities around the world."

Answered by AI

What is the aggregate amount of individuals participating in this research?

"Unfortunately, this clinical trial is not taking new recruits at the moment. Initially advertised on June 1st 2020 and last modified February 3rd 2022 - if you're in search of another study, there are 982 trials actively enrolling Alzheimer's disease patients and 125 recruiting participants for Rapamune."

Answered by AI

Could I be accepted to participate in this experiment?

"To be eligible for this experiment, individuals must suffer from Alzheimer's disease and fall between the ages of 55 to 85. The trial is in search of 10 participants total."

Answered by AI

In what ways has Rapamune been found to be beneficial?

"To prevent organ rejection, Rapamune may be prescribed for liver transplant patients and those suffering from kidney disease or renal angiomyolipomas."

Answered by AI

Are participants of the trial restricted to those under thirty years of age?

"This clinical trial requires individuals of ages 55 to 85. In comparison, there are 98 trials available for people under 18 and 1033 specifically designed for those above the age of 65."

Answered by AI

Is there still room in this trial for new participants?

"Clinicaltrials.gov reveals that this study is no longer actively seeking participants, as it was posted on June 1st 2020 and most recently updated on March 2nd 2022. However, 1107 other medical trials are presently looking for patients to enroll in them."

Answered by AI
~2 spots leftby Mar 2025