A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE St… (NCT05462106) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
United States176 participantsStarted 2022-06-21
Plain-language summary
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.
Who can participate
Age range35 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age ≥50 and ≤85 years at screening.
✓. Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria.
✓. PET scan at screening consistent with the presence of amyloid pathology.
✓. Clinical Dementia Rating (CDR)-Global Score of 0.5.
✓. 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 baseline.
✓. 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).
✓. Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21.
✓. PET scan at screening consistent with the presence of amyloid pathology.
Exclusion criteria
✕. Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study treatment (eg, moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.
✕. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.
What they're measuring
1
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Timeframe: From Screening to Week 74 (Study Part 1)
2
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Timeframe: From Screening to Week 100 (Study Part 2)
3
Number of participants with abnormal MRI results
Timeframe: From Baseline to Week 74 (Study Part 1)
4
Number of participants with abnormal MRI results
Timeframe: From Baseline to Week 100 (Study Part 2)
5
Number of participants with abnormal physical and neurological examination results
Timeframe: From Baseline to Week 74 (Study Part 1)
6
Number of participants with abnormal physical and neurological examination results
Timeframe: From Baseline to Week 100 (Study Part 2)
7
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: From Baseline to Week 74 (Study Part 1)
✕. 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.
✕. Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to AD (eg, 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).
✕. History of meningitis or meningoencephalitis.
✕. History of moderate or severe traumatic brain injury.
✕. History of or presence of inflammatory neurological disorders.
✕. History or presence of immunological or autoimmune disorders.
8
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: From Baseline to Week 100 (Study Part 2)
9
Change from baseline in Anti-Abeta antibody titers in blood
Timeframe: From Baseline to Week 100 (Study Part 2)