Status:
COMPLETED
Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska University Hospital
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
PHASE2
Brief 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 Alzhe...
Eligibility Criteria
Inclusion
- Clinical diagnosis of mild cognitive impairment (MCI), or dementia of Alzheimer's type
- Amyloid positivity established with either amyloid positron emission tomography or cerebrospinal fluid analysis.
- For subjects with dementia, the disease should be in an early stage, operationalized as:
- Stage 4 (Mild dementia) or lower, according to the National Institute on Aging - Alzheimer's Association 2018 clinical staging criteria, AND
- Clinical Dementia Rating Scale (CDR) global score of 1 or lower, AND
- Montreal Cognitive Assessment (MoCA) score of ≥ 18 OR Rey Auditory Verbal Learning Test (RAVLT) \>4 words after 30 minutes
- Capable of giving, and has the capacity to give informed consent
- Availability of a responsible study partner who can accompany the subject to all planned visits
- Male or female between 50 and 80 years
- Normal or clinically acceptable medical history, physical examination, and vital signs
Exclusion
- History of any major disease that may interfere with safe engagement in the intervention (especially severe liver or kidney disease, or uncontrolled diabetes).
- Central nervous system infarct, infection, or focal lesions of clinical significance on MRI scans.
- Fulfills any contraindication for the use of sirolimus as per the summary of product characteristics, including but not restricted to:
- Current or planned medication with a strong inhibitor of CYP3A4 or P-gp
- Current or planned medication with a strong inducer of CYP3A4 or P-gp
- Other current medications with known serious interaction risks with sirolimus
- Known allergy or hypersensitivity to sirolimus
- Significant obesity
- Untreated and clinically significant hyperlipidemia
- Treatment with immunosuppressive medications within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted), or chemotherapeutic agents for malignancy within the last 3 years
- Major surgery within 3 months prior to the planned start of sirolimus treatment, OR has major surgery planned during the period of the trial.
- Use of experimental medications for Alzheimer's or any other investigational medication or device within 60 days. Participants who have been involved in a monoclonal antibody study are excluded unless it is known that they were receiving placebo in that trial
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06022068
Start Date
September 1 2023
End Date
January 17 2025
Last Update
July 3 2025
Active Locations (1)
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1
Karolinska University Hospital Memory clinic
Solna, Stockholm County, Sweden, 171 64