A phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome (ABATE)
EU CTIS ID: 2022-500069-29-00
What this study is testing
Study Part 1: - To assess the safety and tolerability of active study treatments (ACI-24.060 or ACI-24.060 with adjuvant) Study Part 2: To assess the safety and tolerability of ACI-24.060. To assess the anti-Aβ antibody response generated by ACI-24.060 in serum.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part 1 : Age ≥50 and ≤85 years at screening.
- Part 2 : Age ≥35 and ≤50 years at screening (subjects with DS with age ≥35 and ≤39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and/or in biofluids).
- Part 2 : Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21.
- Part 2 : PET scan at screening consistent with the presence of amyloid pathology.
- Part 2 : Subjects, their legal representatives (if applicable) and/or their study partners, in the opinion of the investigator, are able to understand the details of the study and to provide written informed consent before starting any study-related activities.
- Part 2 : In the opinion of the investigator, subjects, their legal representatives (if applicable), and/or their study partners or informants are able to fully participate in the study, are sufficiently proficient in the official languages(s) of the country they are living in, and are capable of reliably completing study assessments.
You likely can't join if
- Part 1 and Part 2 - Comorbidities: Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study treatment (e.g., moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, stroke, or other cerebrovascular conditions), as per investigator’s judgement. A known history of vitamin D deficiency, unless treated with vitamin D replacement for at least 2 months prior to screening. Subjects considered to be at risk of, or exhibiting symptoms or signs suggestive of vitamin D deficiency should undergo testing for serum vitamin D at screening and be excluded if deficiency is detected. Local guidelines for vitamin D supplementation should be applied whenever possible.
- Part 1 and Part 2 - Comorbidities: History or presence of inflammatory neurological disorders including but not limited to neuromyelitis optica spectrum disorder (NMOSD).
- Part 1 and Part 2 - Comorbidities: History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer which have been fully removed and are considered cured.
- Part 1 and Part 2 - Comorbidities: History of chronic or recurrent infections judged to be clinically significant by the investigator and which would potentially hamper the evaluation of efficacy and safety assessments.
- Part 1 and Part 2 - Comorbidities: History or presence of immunological or autoimmune disorders including but not limited to myasthenia gravis, systemic lupus erythematosus, Sjogren syndrome, and sarcoidosis. For autoimmune thyroid disease refer to exclusion criterion No. 42.
- Part 1 and Part 2 - Comorbidities: History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and/or medications.
See the full eligibility criteria
Who can join
- Part 1 : Age ≥50 and ≤85 years at screening.
- Part 2 : Age ≥35 and ≤50 years at screening (subjects with DS with age ≥35 and ≤39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and/or in biofluids).
- Part 2 : Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21.
- Part 2 : PET scan at screening consistent with the presence of amyloid pathology.
- Part 2 : Subjects, their legal representatives (if applicable) and/or their study partners, in the opinion of the investigator, are able to understand the details of the study and to provide written informed consent before starting any study-related activities.
- Part 2 : In the opinion of the investigator, subjects, their legal representatives (if applicable), and/or their study partners or informants are able to fully participate in the study, are sufficiently proficient in the official languages(s) of the country they are living in, and are capable of reliably completing study assessments.
- Part 2 : Females who are either post-menopausal for at least 1 year and/or surgically sterilized, or females of childbearing potential or not post-menopausal must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of their participation. Male participants in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by female partners during the whole study duration.
- Part 2 : Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.
- Part 2 : Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the subject and who is able to provide reliable answers to questions related to the subject, according to the study investigator.
- Part 1 : Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging-Alzheimer’s Association (NIA-AA) criteria.
- Part 1 : PET scan at screening consistent with the presence of amyloid pathology.
- Part 1 : Clinical Dementia Rating (CDR)-Global Score of 0.5.
- Part 1 : Subjects who in the opinion of the investigator are able to understand the details of the study and to provide written informed consent.
- Part 1 : Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and/or memantine for at least 2 months prior to screening.
- Part 1 : Subjects cared for by a reliable spouse, informant, or study partner to assure compliance, assist with clinical assessments, and report safety issues, and spouse, informant or study partner consents to serve in this role.
- Part 1 : Females who are either post-menopausal for at least 1 year and/or surgically sterilized, or females of childbearing potential or not post-menopausal must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of their participation. Male participants in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by female partners during the whole study duration.
- Part 1 : Subjects and study partners must be sufficiently proficient in the official language(s) of the country they are living in and able to comply with all study procedures, including lumbar punctures.
What rules you out
- Part 1 and Part 2 - Comorbidities: Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study treatment (e.g., moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, stroke, or other cerebrovascular conditions), as per investigator’s judgement. A known history of vitamin D deficiency, unless treated with vitamin D replacement for at least 2 months prior to screening. Subjects considered to be at risk of, or exhibiting symptoms or signs suggestive of vitamin D deficiency should undergo testing for serum vitamin D at screening and be excluded if deficiency is detected. Local guidelines for vitamin D supplementation should be applied whenever possible.
- Part 1 and Part 2 - Comorbidities: History or presence of inflammatory neurological disorders including but not limited to neuromyelitis optica spectrum disorder (NMOSD).
- Part 1 and Part 2 - Comorbidities: History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer which have been fully removed and are considered cured.
- Part 1 and Part 2 - Comorbidities: History of chronic or recurrent infections judged to be clinically significant by the investigator and which would potentially hamper the evaluation of efficacy and safety assessments.
- Part 1 and Part 2 - Comorbidities: History or presence of immunological or autoimmune disorders including but not limited to myasthenia gravis, systemic lupus erythematosus, Sjogren syndrome, and sarcoidosis. For autoimmune thyroid disease refer to exclusion criterion No. 42.
- Part 1 and Part 2 - Comorbidities: History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and/or medications.
- Part 1 and Part 2 - Comorbidities: Clinically significant abnormal vital signs including sustained sitting blood pressure >160/90 mm Hg.
- Part 1 and Part 2 - Comorbidities: Significant risk of suicide, defined using the C-SSRS as the subject answering “yes” to suicidal ideation questions 4 or 5 or answering “yes” to suicidal behavior within the past 12 months.
- Part 1 and Part 2 - Comorbidities: Clinically significant infections or major surgical operation within 3 months prior to screening.
- Part 1 and Part 2 - Comorbidities: Planned surgery anticipated to occur during participation in the study must be reviewed and approved by the medical monitor at screening.
- Part 1 and Part 2 - Comorbidities: Subjects who have donated blood or blood products in the 30 days before screening or who plan to donate blood while participating in the study.
- Part 1 and Part 2 - Comorbidities: Subjects considered to be unable to be compliant with study-related activities (eg, completion of any study exams and assessments, respect of visit schedule and/or treatment administration) and/or to have comorbidities preventing the completion of any study exams and assessments (eg, significant hearing or visual impairments or other disabilities) according to the investigator.
- Part 1 and Part 2 - Comorbidities: Subjects with clinically uncontrolled diabetes mellitus and/or with hemoglobin A1c levels of ≥8.0 %.
- Part 1 and Part 2 - Comorbidities: DSM-5 criteria for substance use disorders (with the exception of tobacco use disorder) currently met within the past 5 years.
- Part 1 and Part 2 - Comorbidities: History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted.
- Part 1 and Part 2 - Comorbidities: Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening.
- Part 1 and Part 2 - Comorbidities: Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disease.
- Part 1 and Part 2 - Comorbidities: Concomitant or history of clinically significant and/or unstable psychiatric or neurologic disorder other than those considered to be related to AD (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson’s disease, severe carotid occlusive disease, transient ischemic attacks [TIAs],, hemorrhagic and/or non-hemorrhagic stroke). Subjects with a history of major depressive disorder may be included if they have been free of major episodes for at least 1 year before screening.
- Part 1 and Part 2 - Comorbidities: History of meningitis or meningoencephalitis
- Part 1 and Part 2 - Comorbidities: History of moderate or severe traumatic brain injury.
The study team makes the final eligibility decision.
Where it's taking place
- Spain
- United States
- United Kingdom
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, but 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Spain; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.