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ERAP

CompletedPhase 1 / PHASE2

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

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

Asset

Sirolimus

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMoCA ≥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

Org study ID2023-00611-01
NCT IDNCT06022068

Timeline

Milestones

Study first posted2023-09-01actual
Study start2023-09-01actual
Primary completion2024-12-11actual
Study completion2025-01-17actual
Last update posted2025-07-03actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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:

-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

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:

-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

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

Safety / tolerability / PK
4
Other (unclassified)
3
Amyloid biomarkers
2
Tau biomarkers
2
Global cognition
1
Executive function / language
1
Neurodegeneration biomarkers
1
Neuroimaging
1
Fluid / digital biomarkers
1
Other clinical outcomes
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change 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 endpoint
Other/protocol endpoint

Change in composite z-score of neuropsychological tests

Time frame:From baseline to six months

change from baseline, improvement

Amyloid biomarkers

2 endpoints
Secondary/protocol endpoint

Change in Cerebrospinal fluid (CSF) concentration of amyloid beta 42

Time frame:From baseline to six months

change from baseline, improvement

Other/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change in CSF concentration of phosphorylated tau

Time frame:From baseline to six months

change from baseline, improvement

Secondary/protocol endpoint

Change in CSF concentration of total tau

Time frame:From baseline to six months

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint
Other/protocol endpoint

Change in concentration of neurofilament light in CSF

Time frame:From baseline to six months

Neurofilament light (NfL)

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change in cerebral blood flow

Time frame:From baseline to six months

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Other/protocol endpoint

Change in quotient of albumin concentration in serum and CSF

Time frame:From baseline to six months

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events

Time frame:From baseline to six months

event count, event

Secondary/protocol endpoint

Area under the concentration versus time curve (AUC) of sirolimus

Time frame:Tested at one occasion between baseline to six months

concentration, descriptive

Secondary/protocol endpoint

Peak Plasma Concentration (Cmax) of sirolimus

Time frame:Tested at one occasion between baseline to six months

concentration, descriptive

Secondary/protocol endpoint

Trough Plasma Concentration (Cmin) of sirolimus

Time frame:Tested at one occasion between baseline to six months

concentration, descriptive

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Change in hand-grip strength

Time frame:From baseline to six months

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Change in cerebral glucose metabolism

Time frame:From baseline to six months

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in chair stand test

Time frame:From baseline to six months

change from baseline, improvement

Other/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.