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New treatment option for Amyloid Plaque
Official title A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
ClinicalTrials.gov ID: NCT05462106
What this study is testing
What is ACI-24.060 at Dose A in Study Part 1a?
ACI-24.060 at Dose A in Study Part 1a is an investigational medicine, being studied as a potential treatment for amyloid plaque.
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 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.
- Phase 2: a mid-size study of how well it works
- 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 35 to 85
You may be able to join if
- Study Part 1a and Part 1b
- 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.
You likely can't join if
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or how well it works of the study...
- DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the...
- History or presence of uncontrolled seizures. If there is a history of seizures, they must be well controlled, with no occurrence of seizures in the...
- Concomitant or history of clinically significant and/or unstable psychiatric or neurologic disorder other than those considered to be related to AD...
- History of meningitis or meningoencephalitis.
- History of moderate or severe traumatic brain injury.
See the full eligibility criteria
Who can join
- Study Part 1a and Part 1b
- 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.
- people 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. Study Part 2
- Age ≥35 and ≤50 years at screening (people 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...
- Male or female people with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of chromosome 21.
- PET scan at screening consistent with the presence of amyloid pathology.
- Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.
- people 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...
What rules you out
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or how well it works of the study treatment (eg, moderate and/or severe untreated obstructive sleep apnea...
- DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the past 5 years.
- History or presence of uncontrolled seizures. If there is a 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...
- Concomitant or history of clinically significant and/or unstable psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke...
- History of meningitis or meningoencephalitis.
- History of moderate or severe traumatic brain injury.
- History or presence of inflammatory neurological disorders.
- History or presence of immunological or autoimmune disorders.
- History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and/or medications.
- 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.
- MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a previous macro-hemorrhage or showing more than 4 cerebral microhemorrhages (regardless of their anatomical...
- Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.
- people with a positive Human Immunodeficiency Virus (HIV-1 and 2) test at screening.
- people with clinical or laboratory evidence of active hepatitis B or C at screening (eg, HBV or HCV antigens).
- people with positive syphilis serology consistent with active syphilis at screening.
- people with presence of antibody titers related to immunological or autoimmune disorders at screening.
- MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI and/or severe claustrophobia.
- Any contraindication for PET scan imaging.
- Any contraindication to lumbar puncture in people undergoing this procedure (note: lumbar puncture is optional in people with DS).
- Previous treatment with ACI-24 or any other active immunotherapy against AD at any time in the past unless there is firm evidence that the subject received placebo only and the placebo formulation is not expected to...
- Previous treatment with any investigational and/or marketed passive immunotherapy against AD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the subject received...
- Ongoing treatment with any approved anti-amyloid passive immunotherapy for Alzheimer's disease.
- Use of acetylcholinesterase inhibitor or glutamatergic drugs (eg, memantine, topiramate, lamotrigine) if not on stable dose for at least 2 months before screening.
- Any vaccine, either live or not, including but not limited to influenza or COVID-19 vaccine, received within 4 weeks before randomization.
- people with treated hypothyroidism not on a stable dose of replacement medication for at least 2 months before screening and having clinically significant abnormal serum T4 and/or thyroid stimulating hormone at...
- people undergoing lumbar puncture and being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower.
- Use of antidepressants (other than selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors at stable dose); typical antipsychotics; γ-aminobutyric acid agonists (eg, gabapentin); or...
- Chronic use of opioid analgesics. A limited treatment duration for acute conditions until 24 hours before cognitive assessment is allowed.
- Current use of immunosuppressant or immunomodulating drugs or their use within the 6 months before study screening. Current use of oral steroids or their use within the 3 months before study screening. Additional...
- Clinical diagnosis of AD dementia in DS as per International Classification of Diseases 10 (ICD-10).
- DSQIID \>20.
- Intelligence quotient score \<40 (KBIT-2).
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Lady Lake, Florida, United States
- Orlando, Florida, United States
- The Villages, Florida, United States
- Indianapolis, Indiana, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Matthews, North Carolina, United States
- Cordova, Tennessee, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Barcelona, Spain
- Granada, Spain
- Madrid, Spain
- Santander, Spain
- Valencia, Spain
- Cambridge, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
+ 2 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, 35 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Lady Lake, Florida, United States; Orlando, Florida, United States; The Villages, Florida, United States; Indianapolis, Indiana, United States; Fairway, Kansas, United States and 16 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.