- 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 — Recruiting • Phase II • Neurology • NCT06647498.
- What is being tested: Remternetug, a potential disease-modifying treatment, is being evaluated for its effectiveness in slowing cognitive decline in asymptomatic individuals at risk for early-onset Alzheimer's disease who carry AD-causing genetic mutations.
- Patient eligibility overview: The trial enrolls genetically at-risk individuals (asymptomatic carriers of AD mutations) and those with early symptomatic disease, focusing on familial forms of Alzheimer's disease with identifiable pathogenic variants.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : 1. 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 applicable, country specific ICFs.
- Participant is at least 18 years old. 3. People of childbearing potential 1. Must have a negative serum pregnancy test at screening (V1) 2. Must agree not to try to become pregnant from the time of signed ICF until twenty (20) weeks after the last dose of any study drug. 3. Must agree not to breastfeed from the time of signed ICF until twenty (20) weeks after the last dose of any study drug. 4. If partner is not sterilized, must agree to use highly effective contraceptive measures, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly from screening (V1) until twenty (20) weeks after last dose of any study drug. i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal ii. progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable iii. intra-uterine device (IUD) iv. intrauterine hormone-releasing systems (IUS) v. bilateral tubal occlusion…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.