RECRUITING

Rapamycin - Effects on Alzheimer's and Cognitive Health

Conditions

Mild Cognitive Impairment Alzheimer Disease Cognition Alzheimer's disease biomarkers Neuroimaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD).

Official Title

Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)

Quick Facts

Study Start:2021-08-11

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04629495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Both genders and all ethnic groups 2. Ages 55 to 89 years 3. 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) 4. Amyloid positivity based on Amyloid PET Imaging 5. Labs: Normal blood cell counts without clinically significant excursions; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Fasting lipid panel and prothrombin time/prothrombin time test/international normalized ration (PT/PTT/INR) within normal limits 6. A legally authorized representative (LAR) designated to sign informed consent (if necessary) must attend the Screening visit and accompany the participant to all remaining visits to provide reported outcomes 7. Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed	1. Diabetes (HBA1c≥6.5% or antidiabetic medications) 2. History of skin ulcers or poor wound healing 3. Current tobacco or illicit drug use or alcohol abuse 4. Use of anti-platelet or anti-coagulant medications other than aspirin 5. Current medications that affect cytochrome 450 3A4 (CYP3A4) 6. Immunosuppressant therapy within the last year 7. Chemotherapy or radiation treatment within the last year 8. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities 9. Untreated hypertriglyceridemia (fasting triglycerides \< 250 mg/dl) 10. Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%) 11. Chronic heart failure 12. Pregnancy or lactation 13. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack 14. Significant neurological conditions other than AD or MCI 15. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg - based on two readings) 16. Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness 17. History of, or MRI, or CT positive for, any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindications to lumbar puncture 18. Organ transplant recipients

Inclusion Criteria

Exclusion Criteria

1. Both genders and all ethnic groups
2. Ages 55 to 89 years
3. 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)
4. Amyloid positivity based on Amyloid PET Imaging
5. Labs: Normal blood cell counts without clinically significant excursions; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Fasting lipid panel and prothrombin time/prothrombin time test/international normalized ration (PT/PTT/INR) within normal limits
6. A legally authorized representative (LAR) designated to sign informed consent (if necessary) must attend the Screening visit and accompany the participant to all remaining visits to provide reported outcomes
7. Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed

1. Diabetes (HBA1c≥6.5% or antidiabetic medications)
2. History of skin ulcers or poor wound healing
3. Current tobacco or illicit drug use or alcohol abuse
4. Use of anti-platelet or anti-coagulant medications other than aspirin
5. Current medications that affect cytochrome 450 3A4 (CYP3A4)
6. Immunosuppressant therapy within the last year
7. Chemotherapy or radiation treatment within the last year
8. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
9. Untreated hypertriglyceridemia (fasting triglycerides \< 250 mg/dl)
10. Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%)
11. Chronic heart failure
12. Pregnancy or lactation
13. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
14. Significant neurological conditions other than AD or MCI
15. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg - based on two readings)
16. Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
17. History of, or MRI, or CT positive for, any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindications to lumbar puncture
18. Organ transplant recipients

Contacts and Locations

Study Contact

Sudha Seshadri, MD

CONTACT

210-450-8437

seshadri@uthscsa.edu

Floyd A Jones

CONTACT

210-450-3158

jonesfa@uthscsa.edu

Principal Investigator

Sudha J Seshadri, MD

PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Mitzi J Gonzales, PhD

PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Study Locations (Sites)

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Sudha J Seshadri, MD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio
Mitzi J Gonzales, PhD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-11

Study Completion Date2026-03

Study Record Updates

Study Start Date2021-08-11

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Cognition
Alzheimer's disease biomarkers
Neuroimaging

Additional Relevant MeSH Terms

Mild Cognitive Impairment
Alzheimer Disease