ClinicaliQ Trial Snapshot
- A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation — Recruiting • Phase II • Neurology • NCT05552157.
- What is being tested: Investigational disease-modifying treatments in individuals carrying genetic mutations that cause early-onset Alzheimer's disease, with evaluation of biomarker effects, safety, and tolerability; Stage 1 aims to determine whether treatment prevents or slows disease progression.
- Patient eligibility overview: Participants must have a known Alzheimer's disease-causing genetic mutation and be either at-risk for or have early-onset AD; this represents a genetically defined, high-risk population suitable for early intervention studies.
Use This Page For
- 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.
What This Trial Is Studying
The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group…
Eligibility Snapshot
- : 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.