Health TrialsbyHealthPanel

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

ConditionsAmyloid PlaqueBeta-AmyloidDSADProdromal Alzheimer's DiseaseAlzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age35-85
SponsorAC Immune SA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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 is permitted.

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, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, 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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Placebo (Study Part 1a)

    Biological/Vaccine

    Administration of Placebo in Study Part 1a

  • ACI-24.060 at Dose A in Study Part 1a

    Biological/Vaccine

    Administration of Dose A of ACI-24.060 in Study Part 1a

  • ACI-24.060 at Dose B in Study Part 1a

    Biological/Vaccine

    Administration of Dose B of ACI-24.060 in Study Part 1a

  • ACI-24.060 at Dose C in Study Part 1a

    Biological/Vaccine

    Administration of Dose C of ACI-24.060 in Study Part 1a

  • ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b

    Biological/Vaccine

    Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b

  • Placebo (Study Part 2)

    Biological/Vaccine

    Administration of Placebo in Study Part 2

  • ACI-24.060 at Dose A in Study Part 2

    Biological/Vaccine

    Administration of Dose A of ACI-24.060 in Study Part 2. Dose A will be a dose already tested in Study Part 1a

  • ACI-24.060 at Dose B in Study Part 2

    Biological/Vaccine

    Administration of Dose B of ACI-24.060 in Study Part 2

  • ACI-24.060 at Dose C in Study Part 2

    Biological/Vaccine

    Administration of Dose C of ACI-24.060 in Study Part 2

  • Placebo (Study Part 1b)

    Biological/Vaccine

    Administration of Placebo in Study Part 1b

  • ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b

    Biological/Vaccine

    Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b

Treatment groups

304 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Placebo for Study Part 1a (Prodromal AD)Placebo comparator 1 intervention
Group B: ACI-24.060 at Dose A in Prodromal ADExperimental treatment 1 intervention
Group C: ACI-24.060 at Dose B in Prodromal ADExperimental treatment 1 intervention
Group D: ACI-24.060 at Dose C in Prodromal ADExperimental treatment 1 intervention
Group E: ACI-24.060 with an additional adjuvant at Dose D in Prodromal ADExperimental treatment 1 intervention
Group F: Placebo for Study Part 2 (Down syndrome)Placebo comparator 1 intervention
Group G: ACI-24.060 at Dose A in Down syndromeExperimental treatment 1 intervention
Group H: ACI-24.060 at Dose B in Down syndromeExperimental treatment 1 intervention
Group I: ACI-24.060 at Dose C in Down syndromeExperimental treatment 1 intervention
Group J: ACI-24.060 with an additional adjuvant at Dose E in Prodromal ADExperimental treatment 1 intervention
Group K: Placebo for Study Part 1b (Prodromal AD)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)

Time frame
From Screening to Week 74 (Study Part 1a) and from Screening to Week 100 (Study Part 1b)
2

Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)

Time frame
From Screening to Week 100 (Study Part 2)
3

Number of participants with abnormal MRI results

Time frame
From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
4

Number of participants with abnormal MRI results

Time frame
From Baseline to Week 100 (Study Part 2)

Secondary outcomes

1

Change from baseline in Anti-Abeta antibody titers

Time frame
From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
2

Change from baseline on brain amyloid levels

Brain amyloid load measured via PET imaging. An increase indicates a worsening.

Time frame
From Baseline to W100 (Study Part 2)

Other outcomes

1

Change from baseline on brain amyloid levels

Brain amyloid load measured via PET imaging. An increase indicates a worsening.

Time frame
From Baseline to W48 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
2

Change from baseline on tau levels

Brain tau load measured via PET imaging. An increase indicates a worsening.

Time frame
From Baseline to W48 (Study Part 1a) and to W100 (Study Part 2)
3

Change from baseline in cognitive tests - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.

Time frame
From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
4

Change from baseline in cognitive tests - Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 item (ADAS-Cog 13)

The score ranges from 0 to 85. A higher score indicates a worse outcome.

Time frame
From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AC Immune SA

Lead sponsor

Worldwide Clinical Trials

Collaborator

Source ClinicalTrials.gov
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