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ERAP
CompletedPhase 1 / PHASE2Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography
Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography (ERAP)
Lead sponsor
Asset
Sirolimus
Listed sites
1
Recruiting sites
-
Enrollment
14
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MoCA ≥18
Primary endpoint
•Cerebral glucose metabolism
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Clinical diagnosis of mild cognitive impairment (MCI), or dementia of Alzheimer's type
2. Amyloid positivity established with either amyloid positron emission tomography or cerebrospinal fluid analysis.
3. For subjects with dementia, the disease should be in an early stage, operationalized as:
4. Capable of giving, and has the capacity to give informed consent
5. Availability of a responsible study partner who can accompany the subject to all planned visits
6. Male or female between 50 and 80 years
7. Normal or clinically acceptable medical history, physical examination, and vital signs
Exclusion criteria
1. History of any major disease that may interfere with safe engagement in the intervention (especially severe liver or kidney disease, or uncontrolled diabetes).
2. Central nervous system infarct, infection, or focal lesions of clinical significance on MRI scans.
3. Fulfills any contraindication for the use of sirolimus as per the summary of product characteristics, including but not restricted to:
4. Significant obesity
5. Untreated and clinically significant hyperlipidemia
6. 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
7. Major surgery within 3 months prior to the planned start of sirolimus treatment, OR has major surgery planned during the period of the trial.
8. 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
Endpoints (17)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChange in Montreal Cognitive Assessment (MoCA) rating
Time frame:From baseline to six months
Montreal Cognitive Assessment (MoCA)
change from baseline, improvement
Executive function / language
1 endpointChange in composite z-score of neuropsychological tests
Time frame:From baseline to six months
change from baseline, improvement
Amyloid biomarkers
2 endpointsChange in Cerebrospinal fluid (CSF) concentration of amyloid beta 42
Time frame:From baseline to six months
change from baseline, improvement
Change in ratio of CSF concentration of amyloid beta 42 and 40
Time frame:From baseline to six months
change from baseline, improvement
Tau biomarkers
2 endpointsChange in CSF concentration of phosphorylated tau
Time frame:From baseline to six months
change from baseline, improvement
Change in CSF concentration of total tau
Time frame:From baseline to six months
change from baseline, improvement
Neurodegeneration biomarkers
1 endpointChange in concentration of neurofilament light in CSF
Time frame:From baseline to six months
Neurofilament light (NfL)
change from baseline, improvement
Neuroimaging
1 endpointChange in cerebral blood flow
Time frame:From baseline to six months
change from baseline, improvement
Fluid / digital biomarkers
1 endpointChange in quotient of albumin concentration in serum and CSF
Time frame:From baseline to six months
change from baseline, improvement
Safety / tolerability / PK
4 endpointsIncidence of Treatment-Emergent Adverse Events
Time frame:From baseline to six months
event count, event
Area under the concentration versus time curve (AUC) of sirolimus
Time frame:Tested at one occasion between baseline to six months
concentration, descriptive
Peak Plasma Concentration (Cmax) of sirolimus
Time frame:Tested at one occasion between baseline to six months
concentration, descriptive
Trough Plasma Concentration (Cmin) of sirolimus
Time frame:Tested at one occasion between baseline to six months
concentration, descriptive
Other clinical outcomes
1 endpointChange in hand-grip strength
Time frame:From baseline to six months
change from baseline, improvement
Other (unclassified)
3 endpointsChange in cerebral glucose metabolism
Time frame:From baseline to six months
change from baseline, improvement
Change in chair stand test
Time frame:From baseline to six months
change from baseline, improvement
Change in walking speed
Time frame:From baseline to six months
change from baseline, improvement
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID38575854via DERIVED
- PMID41046300via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.