At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Remternetug (drug), Matching Placebo (Remternetug) (drug)
- How long the study runs
- Study runs about 117 months (dates as stated)
- About the drug or intervention
- Remternetug — drug: Administered subcutaneously every 12 weeks · Matching Placebo (Remternetug) — drug: Administered as subcutaneous injection of placebo every 12 weeks
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a potential disease-modifying treatment for people at risk of, or with, an early-onset form of Alzheimer's disease caused by an inherited genetic change (known as dominantly inherited Alzheimer's disease). It is for people who carry or may have inherited a change in the APP, PSEN1, or PSEN2 gene. The study is sponsored by Washington University School of Medicine.
Who can take part
- You are at least 18 years old and can give written informed consent (you and a study partner, or a legal representative if needed)
- You carry a change (mutation) in the APP, PSEN1, or PSEN2 gene linked to this inherited type of Alzheimer's, or you don't know your status but the change runs in your family and you are directly at risk of having it
- You are estimated to be 11 to 25 years before the age at which your thinking and memory symptoms are predicted to start
- Your thinking and memory are currently normal (a score of 0 on a test called the CDR-SB)
- You speak a language fluently that the study's memory and thinking tests are available in
- Your sight and hearing are good enough to do all the tests
- Any regular medicines you take for other health conditions have been on a stable dose for at least 30 days before the baseline visit
- You have a study partner (such as a family member or friend) who knows you well, agrees to attend visits and answer questions about your memory and daily abilities, and signs the consent form if needed
- You agree not to donate blood from screening, during the study, and for 5 half-lives after the final dose of study drug
- You are willing and likely to complete all study tests, checks and procedures
- If you could become pregnant: a negative pregnancy test at screening, agreement not to try to become pregnant or breastfeed until 20 weeks after the last dose, and use of a highly effective contraceptive (for example an IUD, implant, or sterilised partner) unless your partner is sterilised
Who may not be able to
- Significant brain (other than Alzheimer's) or mental health conditions that could affect your memory or ability to take part, such as severe head injury, seizures, other degenerative brain diseases, schizophrenia, bipolar disorder, or major depression
- High risk of suicide, for example serious suicidal thoughts or an attempt in the last 12 months, or a high score on a suicide-risk screening questionnaire (stable mild depression or antidepressant use is allowed)
- History of stroke, major narrowing of neck or brain arteries, or other strong risk factors for stroke or bleeding in the brain (including atrial fibrillation, blood thinners, or a TIA (transient ischaemic attack, sometimes called a mini-stroke) in the last 12 months)
- Alcohol or drug use problems, currently or within the past year
- A brain scan showing certain abnormalities, such as microbleeds, bruising, scarring, or aneurysms (minor findings are allowed)
- Certain implanted metal devices (such as some pacemakers, aneurysm clips, artificial heart valves, or ear implants) or metal in the eyes, skin or body that would make MRI (magnetic resonance imaging) scans unsafe
- Heart problems such as uncontrolled high blood pressure, past heart attack, heart failure, atrial fibrillation, or a long QT interval on a heart trace (ECG) that could interfere with the study
- Liver or kidney problems that could interfere with the study
- HIV infection, Hepatitis B in the past year, untreated Hepatitis C, or past syphilis or Lyme infection affecting the brain or spinal cord
- Severe or multiple drug allergies, or serious skin reactions after treatment, or sensitivity to the PET (positron emission tomography) scanning substances used in this study
- Taking medicines that suppress the immune system (for example steroid tablets) in the past 90 days (inhaled, nasal, or skin steroids are allowed), or chemotherapy in the past 3 years
- Thyroid problems or low vitamin B12 that are clinically significant
- Unstable or poorly controlled diabetes (you may be able to be re-screened after 3 months)
- Severe obesity with significant other health problems, or that would prevent MRI scanning
- Taking blood-thinning medicines such as warfarin, dabigatran, rivaroxaban, or apixaban (daily low-dose aspirin under 325 mg is allowed)
- Having had a monoclonal antibody treatment targeting amyloid (a protein linked to Alzheimer's) in the past 6 months or 5 half-lives, whichever is longer
- Having had another experimental drug treatment in the past 3 months or 5 half-lives, whichever is longer (approved Alzheimer's medicines may be allowed)
- Poor veins that make blood tests difficult
- Abnormal blood test results that matter clinically
- A history of cancer with a high risk of coming back and affecting the study
- Any other condition that could affect your mental or physical status enough to bias the study or put you at extra risk
- Taking part in another clinical study now or in the past month without prior approval
- Having the 'Dutch' APP E693Q mutation
- A screening brain scan showing ARIA-E (brain swelling or fluid changes), more than 4 microbleeds, any superficial siderosis (iron deposits on the brain surface), any larger bleed, or severe white matter disease
- Exposure to lecanemab, donanemab, or other experimental amyloid-lowering treatments in the past 6 months or 5 half-lives, whichever is longer
- Being study staff on this trial or their close family, or being an employee of the sponsor (Lilly) or a third-party organisation involved in the study, or having a study partner who is
What taking part involves
- • Not stated — ask the trial team (the study tests a potential disease-modifying treatment for a genetically caused early-onset type of Alzheimer's disease, but details of the treatment itself, such as what form it takes, are not stated)
Time commitment: Not stated — ask the trial team (the study involves screening and baseline visits, memory and thinking tests, MRI and PET scans, blood tests, and a study partner attending visits, but the total number of visits and study length are not stated).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 280
- Started
- 2024-11-22
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for alzheimers disease
- • Phase2/Phase3 - 280 participants
- • The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with alzheimers disease
Where?
- • London - The National Hospital for Neurology and Neurosurgery
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.
More detail
Alzheimer's disease (AD) is an age-related neurodegenerative disorder characterized by progressive decline in cognitive function and the ability to perform activities of daily living. The amyloid hypothesis of AD postulates that the accumulation of amyloid beta (Aβ) is an early and necessary event in the pathogenesis of AD. This hypothesis suggests that interventions that slow the accumulation of Aβ plaque in the brain or increase clearance of Aβ may be able to slow the progression of the AD clinical syndrome. AD occurs on a continuum from asymptomatic (preclinical) to mild cognitive impairment (MCI), and then to dementia in mild, moderate, and severe stages. Evidence from both genetic at-risk and age at-risk cohorts, such as in dominantly inherited AD (DIAD) suggests that the pathophysiological process of AD begins well more than a decade before the clinical stage now recognized as AD dementia, and that neurodegeneration is already apparent on MRI by the stage of mild cognitive impairment. Recent clinical trial data suggest that treating AD during the earlier stages could have the greatest potential benefit on the disease by slowing progression The ability to identify individuals destined to develop Alzheimer's disease (AD) with a high degree of confidence provides a unique opportunity to assess the efficacy of therapies at asymptomatic and very early stages of dementia. Families with known disease-causing mutations are extremely rare and are geographically dispersed throughout the world. Participants in this study will not yet have developed any clinical symptoms of AD; they will be "asymptomatic" carriers of mutations that cause DIAD and would be expected to perform normally on standard cognitive and functional testing. Further, most mutation carriers will have levels of AD-associated amyloid beta (Aβ) and non-Aβ biomarkers that are the same as non-carriers. Amyloid beta is a protein that accumulates in the brain of people with AD. Although we do not understand exactly what causes AD, the abnormal accumulation of amyloid beta protein in the brain is thought to play an important role in the symptoms of AD. Recent research studies indicate that amyloid beta may start building up in the brain 15 years or more before the onset of memory loss. Imaging and fluid biomarkers will be used to demonstrate that the treatment compounds have engaged their therapeutic targets. A set of cognitive measures designed to assess the very earliest and most subtle cognitive changes will be collected. The overall objectives of this study are to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an AD-causing mutation. The primary objective of Stage 1 is to determine if treatment with the study drug prevents or slows the rate of Aβ pathological disease accumulation demonstrated by Aβ PiB positron emission tomography (PET) imaging. The primary objective of Stage 2 is to evaluate the effect of early anti-amyloid treatment on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, NfL, MRI volume) compared to a control group from the DIAN Obs natural history study and the DIAN-TU-001 placebo-treated participants. Remternetug is a monoclonal antibody. The mechanism of action of remternetug is to target and remove aggregated amyloid plaque, a key pathological hallmark of AD, via microglial-mediated clearance. Remternetug has demonstrated the ability to reduce brain amyloid plaque. The remternetug arm is part of Master Protocol DIAN-TU-002 (NCT05552157)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum pregnancy test at screening (V1)
- ✓ study partner input for scale completion, and who signs the necessary ICF, if applicable
Treatments you must NOT have had:
- ✗ approval
What the study is looking for
- ✓Participant is at least 18 years old.
- ✓People of childbearing potential
- ✓Must have a negative serum pregnancy test at screening (V1)
- ✓Must agree not to try to become pregnant from the time of signed ICF until twenty (20) weeks after the last dose of...
- ✓Must agree not to breastfeed from the time of signed ICF until twenty (20) weeks after the last dose of any the study treatment.
Who cannot take part
- ✗Alcohol or substance use sufficient to meet DSM-V criteria currently or within the past year.
- ✗liver or kidney abnormalities that in the opinion of the investigator would interfere with participation in or...
- ✗Morbid obesity with significant other health conditions or that would preclude MRI imaging.
- ✗Current use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, or apixaban). Daily use of low dose (\< 325...
- ✗Have been exposed to a monoclonal antibody targeting Aβ peptide within the past 6 months or 5 half-lives from...
See the full criteria
Where Is This Study? (1 UK site)
The National Hospital for Neurology and Neurosurgery
London WC1B 3BG, United Kingdom
How to Get in Touch
Jamie Bartzel
Sponsor contactCONTACT
Ellen Ziegemeier
Sponsor contactCONTACT
