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New treatment option for Alzheimers Disease
Official title A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation
ClinicalTrials.gov ID: NCT06647498
What this study is testing
What is Remternetug?
Remternetug is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for alzheimers disease.
Also referred to as LY3372993.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative...
- 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 during the study until 5 half-lives after the last dose of any study drug.
You likely can't join if
- Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the study affect cognition or the participant's...
- At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months, current major depression (as defined in Diagnostic...
- History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor...
- Alcohol or substance use sufficient to meet DSM-V criteria currently or within the past year.
- History of or Baseline (V2) visit brain MRI scan indicative of any other significant abnormality, definite microhemorrhages, evidence of a cerebral...
- Presence of certain implanted medical devices, such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal...
See the full eligibility criteria
Who can join
- Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if...
- 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 during the study until 5 half-lives after the last dose of any study drug.
- Must agree not to breastfeed from the time of signed ICF until 5 half-lives after the last dose of any study drug.
- If partner is not sterilized, must agree to use highly effective contraceptive measures from screening (V1) until 5 half lives after last dose of any study drug
- Mutation Status:
- Participant is a carrier of a mutation in an APP, PSEN1, or PSEN2 gene that is associated with DIAD or does not know their mutation status and there is a mutation in their family pedigree that puts them at a direct risk...
- Participant is -25 to -11 years from predicted age of cognitive symptom onset based on their mutation type or family pedigree Note: If the at-risk parent is deemed a non-carrier through confirmed genetic testing at any...
- Cognitive status of participant is normal (CDR-SB 0).
- Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning. Participants must be fluent in languages for which cognitive and clinical measures have been translated and...
- Participant has adequate visual and auditory abilities to perform all aspects of the cognitive and clinical assessments.
- Participant is receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to baseline visit (V2) except for medications taken for episodic conditions (e.g...
- Participant has a study partner who in the PI's judgment can provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at the study visits that require...
- The participant agrees not to donate blood or blood products for transfusion from the time of Screening (V1) for a study drug arm, for the duration of the study, and for 5 half lives after the final dose of study drug.
- In the opinion of the PI, the participant will be compliant and have a high probability of completing the study.
- The participant is able and willing to complete all study-related testing, evaluations, and procedures.
What rules you out
- Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the study affect cognition or the participant's ability to complete the study. This would include disorders such as...
- At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months, current major depression (as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-V]), or...
- History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor for stroke or cerebral hemorrhage (including atrial fibrillation and...
- Alcohol or substance use sufficient to meet DSM-V criteria currently or within the past year.
- History of or Baseline (V2) visit brain MRI scan indicative of any other significant abnormality, definite microhemorrhages, evidence of a cerebral contusion, encephalomalacia, or aneurysms. Minor or clinically...
- Presence of certain implanted medical devices, such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body which would preclude MRI scan.
- Cardiovascular complications such as uncontrolled hypertension, history of myocardial infarcts, heart failure, atrial fibrillation, long QT interval on ECG likely to interfere with participation in or analysis of the...
- Hepatic or renal abnormalities that in the opinion of the investigator would interfere with participation in or analysis of the trial.
- History of Human Immunodeficiency Virus (HIV) infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated, history of spirochete infection...
- History of clinically significant multiple or severe drug allergies, significant atopy, or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear IgA dermatosis...
- Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within 90 days prior to Baseline (V2) visit (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or...
- Current clinically significant abnormalities of thyroid function, or clinically significant deficiency in vitamin B12. Vitamin B12 less than the lower limits of normal with normal methylmalonic acid (MMA)/homocysteine...
- Unstable or poorly controlled diabetes which the investigator believes may interfere with participation in or analysis of the study protocol. Participants may be rescreened after 3 months to allow optimization of...
- Morbid obesity with significant comorbidities or that would preclude MRI imaging.
- Current use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, or apixaban). Daily use of low dose (\< 325 mg) aspirin is not exclusionary.
- Have been exposed to a monoclonal antibody targeting Aβ peptide within the past 6 months or 5 half-lives from screening, whichever is longer.
- Received any other investigational pharmacological treatment within 3 months of Screening or 5 half-lives, whichever is longer. Note: Use of approved treatments for AD and other medications may be permitted in this...
- Lack of sufficient venous access.
- Clinically relevant abnormalities in hematology, coagulation, or clinical chemistry.
- History of cancer that the investigator believes has high risk of recurrence and impacting study participation or analysis.
- Any other medical condition that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the...
- Currently, or within the last month prior to screening, participated in a clinical study, including a nonpharmacological study, without prior approval.
- Participants with the "Dutch" APP E693Q mutation.
- Unable to complete baseline visit (V2) procedures with appropriate cognitive and clinical scores for eligibility
- A centrally read MRI demonstrating presence of ARIA-E, \> 4 cerebral microhemorrhages, any superficial siderosis, any macrohemorrhage, or severe white matter disease at screening.
- Exposure to lecanemab, donanemab, or other investigational amyloid lowering agents within the past 6 months or five half-lives from screening, whichever is longer. Note: Use of approved treatments for AD and other...
- Investigator site personnel directly affiliated with this trial and/or their immediate families, defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Lilly employees or employees of a third-party organization (TPO) involved in this study that requires exclusion of their employees or have study partners who are Lilly employees or are employees of TPOs involved in this...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Ciudad Autonoma de Buenos Aire, Argentina
- Randwick, New South Wales, Australia
- Melbourne, Victoria, Australia
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Verdun, Quebec, Canada
- Québec, Canada
- Medellín, Colombia
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Park Ridge, Illinois, United States; Indianapolis, Indiana, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.