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mTOR inhibitor

Rapamycin for Alzheimer's Disease (REACH Trial)

Phase 2
Recruiting
Led By Sudha J Seshadri, MD
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)
Must not have
Diabetes (HBA1c≥6.5% or antidiabetic medications)
Chronic heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes with HBA1c levels of 6.5% or higher, or I am on medication for it.
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I have been diagnosed with chronic heart failure.
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I am taking blood thinners other than aspirin.
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I do not have active inflammation, COVID-19, autoimmune diseases, infections, liver or stomach issues, cancer, or severe mental illness.
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I have a history of liver or kidney disease.
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I have had skin ulcers or issues with wounds not healing well.
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I am taking medications that interact with CYP3A4.
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I have not taken immunosuppressant drugs in the last year.
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I have not had chemotherapy or radiation in the past year.
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I have a significant neurological condition besides Alzheimer's or mild cognitive impairment.
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I have received an organ transplant.
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I don't have brain lesions that would make a spinal tap unsafe.
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I have a lung condition or my oxygen levels are usually below 90%.

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
476 Previous Clinical Trials
92,935 Total Patients Enrolled
Sudha J Seshadri, MDPrincipal InvestigatorUT Health San Antonio
Mitzi J Gonzales, PhDPrincipal 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
~11 spots leftby Mar 2026
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