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mTOR inhibitor

Rapamycin for Alzheimer's Disease (REACH Trial)

Phase 2
Recruiting
Led By Mitzi J 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
Ages 55 to 89 years
Diagnosis of MCI or AD (Mini Mental Status Examination (MMSE): 18-30; Clinical Dementia Rating Scale (CDR) = 0.5 - 1; California Verbal Learning Test III (CVLT-III) Delayed Recall ≤16% based on age-adjusted norms, clinician approval)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

REACH Trial Summary

This trial will study the effects of a 12-month oral rapamycin treatment in older adults with early stage Alzheimer's disease and amnestic mild cognitive impairment.

Who is the study for?
Adults aged 55-89 with mild cognitive impairment or early Alzheimer's, who have a representative to assist them and are on stable Alzheimer's medication. They must show amyloid presence in PET imaging, have normal organ function and blood counts, and controlled glucose levels. Excluded are those with recent severe illnesses, immunosuppressant use, untreated high triglycerides, heart issues, certain neurological conditions other than AD/MCI.Check my eligibility
What is being tested?
The trial is testing the safety of rapamycin over a year in older adults with memory loss due to mild cognitive impairment or early Alzheimer's disease. Participants will either receive rapamycin or a placebo (a substance with no therapeutic effect) to compare outcomes.See study design
What are the potential side effects?
Rapamycin may cause side effects such as increased risk of infections due to its immune-suppressing properties; it can also affect liver and kidney function tests, cholesterol levels (lipid panel), blood sugar control (HbA1c), and wound healing.

REACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 89 years old.
Select...
I have been diagnosed with mild cognitive impairment or Alzheimer's disease.

REACH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in albumin
Change in calcium
Change in carbon dioxide or bicarbonate (CO2)
+2 more
Secondary outcome measures
Central nervous system penetration of rapamycin
Change in Brain Volumetry
Change in CSF amyloid beta
+7 more

REACH Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: RAPA (rapamycin) treatment groupActive Control1 Intervention
Subjects will receive active drug
Group II: Placebo groupPlacebo Group1 Intervention
Subjects will receive placebo

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,370 Total Patients Enrolled
Mitzi J Gonzales, PhDPrincipal InvestigatorUT Health San Antonio
Sudha J Seshadri, MDPrincipal InvestigatorUT Health San Antonio

Media Library

Rapamycin (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04629495 — Phase 2
Alzheimer's Disease Research Study Groups: Placebo group, RAPA (rapamycin) treatment group
Alzheimer's Disease Clinical Trial 2023: Rapamycin Highlights & Side Effects. Trial Name: NCT04629495 — Phase 2
Rapamycin (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629495 — Phase 2

Frequently Asked Questions

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

What medical conditions does RAPA (rapamycin) therapy typically address?

"Under the RAPA (rapamycin) treatment arm, there are therapeutic options for organ transplant rejection and related diseases such as kidney disease and renal angiomyolipomas."

Answered by AI

What aims has this trial set out to achieve?

"The primary evaluation criterion of this trial, which will be monitored over a baseline to 12-month period, is the alteration in glucose levels. Secondary targets include changes in functional status (using the Functional Assessment Scale), cognition (utilizing Preclinical Alzheimer's Cognitive Composite 5) and cerebrospinal fluid amyloid beta concentrations."

Answered by AI

Can individuals currently submit applications for this clinical trial?

"Affirmative, the information on clinicaltrials.gov demonstrates that this research is currently accepting patients. It was originally published on August 11th 2021 and was adjusted as recently as October 10th 2022. The trial requires 40 volunteers to be recruited at a single site."

Answered by AI

What hazards should individuals be aware of with RAPA (rapamycin) therapy?

"Due to the relative lack of evidence supporting efficacy, our team at Power assigned RAPA treatment group a safety score of 2 on a scale from 1-3."

Answered by AI

Is it possible for me to partake in this research venture?

"This clinical trial is seeking 40 individuals who have been diagnosed with Alzheimer's disease and are aged between 55-89. Both genders, as well as all ethnic backgrounds, are eligible to apply for the study."

Answered by AI

To what extent are individuals being monitored in this investigation?

"Affirmative. According to the information on clinicaltrials.gov, this medical study is still recruiting participants. It was published on August 11th 2021 and recent modified October 10th 2022 as it seeks 40 patients from a single trial site."

Answered by AI

Could you provide information pertaining to past experiments utilizing RAPA (rapamycin) therapy?

"Presently, there are 125 live research studies regarding rapamycin therapy with 13 of these in the late-phase trials. While numerous experiments into this treatment group are being conducted within Cincinnati, Ohio, a total of 1074 sites worldwide have initiated clinical trials involving rapamycin."

Answered by AI

Does the enrollment criterion of this trial encompass elderly individuals?

"This clinical trial stipulates that the minimum age for enrolment is 55, while 89 years old marks the upper limit."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rapamycin - Effects on Alzheimer's and Cognitive Health
Mitzi Gonzales, PhD 2021. "Rapamycin - Effects on Alzheimer's and Cognitive Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629495.
All > Alzheimer Disease > Alzheimers Disease
~1 spots leftby Jun 2024
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