NCT06022068

Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography

Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography (ERAP)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This single-center, uncontrolled pilot study aims to evaluate the efficacy, safety, and tolerability of six months of intermittently dosed oral rapamycin (sirolimus) in subjects with early-stage Alzheimer's disease. Fifteen participants will be recruited. Following a set of baseline measurements, all participants will receive a weekly oral dose of 7 mg rapamycin for six months. Participants will be continuously monitored for safety and side effects. At the termination of the treatment, follow-up measurements will be taken. The primary endpoint will be change in cerebral glucose metabolism, measured using 18F labeled fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET). In addition to the registered outcome measures this pilot trial will explore the feasibility of acquiring data on the effect of sirolimus treatment on age-related tissue changes in the body using a variety of imaging modalities, such as bone mineral density assessed using quantitative computed tomography, retinal structures assessed using optical coherence tomography, periodontal tissue assessed using MRI and FDG-PET, cardiac function assessed using MRI, vessel wall in large arteries using MRI and \[18F\]FDG PET.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Sirolimus	7 mg taken once per week during 26 weeks.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-11
• Completion: 2025-01-17
• First posted: 2023-09-01
• Last updated: 2025-07-03

Locations

1 site across 1 country: Sweden