CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Sirolimusdrug
Likely dose
Sirolimus 7 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06022068
NCT06022068Phase 2Completed

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

Karolinska Institutet·interventional·Posted Sep 1, 2023·Updated Jul 3, 2025

In Brief

A Phase 2 clinical trial evaluating Sirolimus for Alzheimer Disease. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden

Timeline

Phase 2CompletedFinished
202420252026
First PostedSep 1, 2023
Enrollment StartSep 1, 2023
Primary CompletionDec 11, 2024
Study CompletionJan 17, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.8 years ago

Interventions

Sirolimusdrug

7 mg taken once per week during 26 weeks.