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

Who is this study for? Patients with mild cognitive impairment or Alzheimer disease
What treatments are being studied? Rapamycin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 89
Healthy Volunteers: f
View:

• Both genders and all ethnic groups

• 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)

• Amyloid positivity based on Amyloid PET Imaging

• 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

• 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

• Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed

Locations
United States
Texas
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
RECRUITING
San Antonio
Contact Information
Primary
Sudha Seshadri, MD
seshadri@uthscsa.edu
210-450-8437
Backup
Floyd A Jones
jonesfa@uthscsa.edu
210-450-3158
Time Frame
Start Date: 2021-08-11
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Active_comparator: RAPA (rapamycin) treatment group
Subjects will receive active drug
Placebo_comparator: Placebo group
Subjects will receive placebo
Authors
Mitzi J Gonzales
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov