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A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease (TREMHANCE)

7 augusti 2026 uppdaterad av: Sanofi

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease

This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.

This Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.

The study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.

Up to 160 participants will be included in this study.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

160

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-post: contact-us@sanofi.com

Studieorter

  • Förenta staterna
    • Florida
      • The Villages, Florida, Förenta staterna, 32162
        • Rekrytering
        • Charter Research - Lady Lake- Site Number : 8400004

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.
  • Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association [NIA-AA] Stage 3) or mild AD dementia (NIA-AA Stage 4).
  • Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.
  • Have a study partner who must provide separate written informed consent at screening. Study partner should be >18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.
  • The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.

Exclusion Criteria:

  • The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).
  • The participant has evidence of more than 4 microhemorrhages (<10 mm in diameter) or superficial siderosis.
  • The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).
  • The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.
  • The participant is currently receiving anticoagulant therapies.
  • The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: SAR448851
Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
Läkemedel: SAR448851
Pharmaceutical form: Capsule Route of administration: Oral
Placebo-jämförare: Placebo
Participants will receive placebo oral daily for 48 weeks
Läkemedel: Placebo
Läkemedelsform: Kapsel Administreringssätt: Oral

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217
Tidsram: From baseline to Week 48
From baseline to Week 48
Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS
Tidsram: From Week 48 to Week 96
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), including amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) by brain magnetic resonance imaging (MRI), laboratory assessments, vital sign measurements, electrocardiograms (ECGs) and the Columbia-Suicide Severity Rating Scale (C-SSRS)
From Week 48 to Week 96

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part A and optional dose 2 cohort: Change from baseline to Week 48 in plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
Tidsram: From baseline to Week 48
From baseline to Week 48
Part A and optional dose 2 cohort: Change from baseline to Week 48 in brain amyloid plaque deposition as measured by amyloid positron emission tomography (PET)
Tidsram: From baseline to Week 48
From baseline to Week 48
Part A and optional dose 2 cohort: Change from baseline to Week 48 in CSF soluble triggering receptor expressed on myeloid cells 2 (sTREM2)
Tidsram: From baseline to Week 48
From baseline to Week 48
Part A and optional dose 2 cohort: Number of participants with TEAEs and serious adverse events (SAEs), and discontinuations due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, ECGs and the C-SSRS)
Tidsram: From baseline to Week 48
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), serious adverse event (SAE) or discontinuation due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, electrocardiograms [ECGs] and the Columbia-Suicide Severity Rating Scale [C-SSRS])
From baseline to Week 48
Part A and optional dose 2 cohort: Number of participants with ARIA-E and ARIA-H assessed by brain MRIs
Tidsram: From baseline to Week 48
Number of participants with amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) assessed by brain magnetic resonance imaging (MRI). ARIA event: adverse event causing brain swelling or bleeding that requires close monitoring.
From baseline to Week 48
Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851
Tidsram: From baseline to Week 48
From baseline to Week 48
Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Tidsram: From baseline to Week 96
Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
From baseline to Week 96
Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Tidsram: From Week 48 to Week 96
Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
From Week 48 to Week 96

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sanofi

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 juli 2026

Primärt slutförande (Beräknad)

31 juli 2029

Avslutad studie (Beräknad)

31 juli 2029

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACT23645
  • 2025-524581-14 (Registeridentifierare: CTIS)
  • U1111-1328-4936 (Registeridentifierare: ICTRP)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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