NCT06022068Befejeződött1/2. fázis
Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography
Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography (ERAP)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 14 (tényleges)
- Első benyújtás
- 2023. aug. 15.
- Kezdés
- 2023. szept. 1.
- Elsődleges befejezés
- 2024. dec. 11.
- Fő szponzor
- Karolinska Institutet
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT06022068
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Bevont résztvevők: 14
- 2023. szept. 1. és az elsődleges befejezés (2024. dec. 11.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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
Más betegség
- 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
Egyéb
- Significant obesity
- Untreated and clinically significant hyperlipidemia
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 50 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Karolinska University Hospital Memory clinic | Solna | Svédország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.