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Dementia, Alzheimer's TypePhase 2TREMHANCENCT07688213

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

A Phase 2 study testing SAR448851 in people with Dementia, Alzheimer's Type and Alzheimer's Disease, run by Sanofi at 20 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 85 years
What is being tested?
SAR448851
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
20 sitesin 6 countries
Study dates
28 Jul 2026to 31 Jul 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

Contact-US@sanofi.com

20 sites in 6 countries

United States10 sites, 10 recruiting

  • Kerwin Medical Center- Site Number : 8400006

    Dallas, Texas, 75231

    Recruiting

  • Healthy Brain Clinic- Site Number : 8400011

    Long Beach, California, 90804

    Recruiting

  • Aqualane Clinical Research- Site Number : 8400001

    Naples, Florida, 34105

    Recruiting

  • Boston Center for Memory - Newton- Site Number : 8400007

    Newton, Massachusetts, 02459

    Recruiting

  • Oakland Clinical- Site Number : 8400010

    Oakland, California, 94609

    Recruiting

  • K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008

    Orlando, Florida, 32751

    Recruiting

  • Flourish Research - Keystone Clinical Studies- Site Number : 8400003

    Plymouth Meeting, Pennsylvania, 19462

    Recruiting

  • Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002

    Portland, Oregon, 97210

    Recruiting

  • The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005

    Springfield, New Jersey, 07081

    Recruiting

  • Charter Research - Lady Lake- Site Number : 8400004

    The Villages, Florida, 32162

    Recruiting

Other trials in United States

United Kingdom4 sites, 4 recruiting

  • Investigational Site Number : 8260004

    Bath, Somerset, BA1 3NG

    Recruiting

  • Investigational Site Number : 8260002

    London, Hammersmith and Fulham, W6 8RF

    Recruiting

  • Investigational Site Number : 8260001

    London, London, City of, NW1 2BU

    Recruiting

  • Investigational Site Number : 8260003

    London, London, City of, SE5 9RL

    Recruiting

Other trials in United Kingdom

Australia3 sites, 3 recruiting

  • Investigational Site Number : 0360003

    Ivanhoe, Victoria, 3081

    Recruiting

  • Investigational Site Number : 0360001

    Macquarie Park, New South Wales, 2113

    Recruiting

  • Investigational Site Number : 0360004

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Canada1 site, 1 recruiting

  • Investigational Site Number : 1240001

    Ottawa, Ontario, K1Z 1G3

    Recruiting

Other trials in Canada

Germany1 site, 1 recruiting

  • Investigational Site Number : 2760002

    Cologne, 50937

    Recruiting

Other trials in Germany

Spain1 site, 1 recruiting

  • Investigational Site Number : 7240003

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Being tested
SAR448851, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR448851Drug

    Pharmaceutical form: Capsule Route of administration: Oral

  • PlaceboDrug

    Pharmaceutical form: Capsule Route of administration: Oral

Study groups in NCT07688213
Study groupRoleWhat they receive
SAR448851ExperimentalParticipants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
Receives: Drug: SAR448851
PlaceboPlacebo comparatorParticipants will receive placebo oral daily for 48 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217

    Measured: From baseline to Week 48

  2. 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

    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)

    Measured: From Week 48 to Week 96

Secondary outcomes (8)

  1. 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)

    Measured: From baseline to Week 48

  2. 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)

    Measured: From baseline to Week 48

  3. Part A and optional dose 2 cohort: Change from baseline to Week 48 in CSF soluble triggering receptor expressed on myeloid cells 2 (sTREM2)

    Measured: From baseline to Week 48

  4. 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)

    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])

    Measured: From baseline to Week 48

  5. Part A and optional dose 2 cohort: Number of participants with ARIA-E and ARIA-H assessed by brain MRIs

    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.

    Measured: From baseline to Week 48

  6. Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851

    Measured: From baseline to Week 48

  7. Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng

    Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)

    Measured: From baseline to Week 96

  8. Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng

    Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)

    Measured: From Week 48 to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start28 Jul 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A and optional dose 2 cohort is a randomized, double-blind, parallel-group, placebo-controlled study with 2 arms in each cohort. Part B is an open-label extension.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688213
Sponsor's protocol ID
ACT23645
Other IDs
2025-524581-14, U1111-1328-4936, 2025
Acronym
TREMHANCE
Status last verified
Oct 2026
First submitted
30 Jun 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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