Dementia Support Line
Tremhance: A trial investigating a a new medicine (SAR448851) in people with early Alzheimer’s disease
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The Clinical Trial Finder is for information only. To join a clinical trial you must meet the eligibility criteria set by the study and the research team will discuss this with you.
Trial description
What is the aim of the study?
This study is testing a new medicine called SAR448851 to see if it can slow down or slow the progression of early Alzheimer's disease (AD). Alzheimer's disease is a brain condition that causes memory loss, thinking problems, and difficulties with daily activities, affecting millions of people worldwide.
SAR448851 works by helping a protein in the brain called TREM2. TREM2 helps the brain clean away harmful substances that can build up and cause problems. Some people have changes in the TREM2 gene that make them more likely to develop Alzheimer's disease. Early studies suggest that helping TREM2 work better may protect the brain and reduce damage caused by Alzheimer's disease.
What will participants be asked to do during the study?
The study drug is a tablet to be taken on an empty stomach – you cannot eat for three hours before and two hours after the study drug. You will be in the study for about two years (102 weeks) including a six-week follow-up after completing treatment.
The study visits and procedures are described below.
Screening is made up of three site visits, procedures include: memory tests, reviewing medical history, physical exam, blood/urine tests, blood sample for gene testing, plasma amyloid test, ECG, MRI brain scan and PET brain scan.
Baseline visit is made up of two onsite visits, procedures include: PET brain scan, lumbar puncture, memory tests, blood tests.
Treatment period is then comprised of 22 visits across two years (15 onsite and seven remote) all of which require a study partner.
Eligibility criteria
You may be able to take part if you:
- have a diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia
- have a study partner (a close friend or family member who can provide information at study visits)
- have a gradual decline in memory function reported by yourself or study partner for > six months
- are on stable doses of all other (such as non-AD-related) medications for at least six weeks prior to Screening.
You may not be able to take part if you:
- have any history of significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other types of dementia, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis or epilepsy or recurrent seizures (except febrile childhood seizures)
- have any history of bleeding in the brain, history of a stroke, or transient ischemic attack (TIA) within 12 months of Screening
Clinical trial team
Age range
Recruitment start
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Eligibility criteria
You may be able to take part if you:
- have a diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia
- have a study partner (a close friend or family member who can provide information at study visits)
- have a gradual decline in memory function reported by yourself or study partner for > six months
- are on stable doses of all other (such as non-AD-related) medications for at least six weeks prior to Screening.
You may not be able to take part if you:
- have any history of significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other types of dementia, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis or epilepsy or recurrent seizures (except febrile childhood seizures)
- have any history of bleeding in the brain, history of a stroke, or transient ischemic attack (TIA) within 12 months of Screening