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

Conditions

• Alzheimer's Disease
• Amyloid Plaque
• Beta-Amyloid
• DSAD
• Prodromal Alzheimer's Disease

Eligibility Criteria

Sex

ALL

Age

35 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo (Study Part 1a) — BIOLOGICAL
  Administration of Placebo in Study Part 1a
• ACI-24.060 at Dose A in Study Part 1a — BIOLOGICAL
  Administration of Dose A of ACI-24.060 in Study Part 1a
• ACI-24.060 at Dose B in Study Part 1a — BIOLOGICAL
  Administration of Dose B of ACI-24.060 in Study Part 1a
• ACI-24.060 at Dose C in Study Part 1a — BIOLOGICAL
  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
  Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
• Placebo (Study Part 2) — BIOLOGICAL
  Administration of Placebo in Study Part 2
• ACI-24.060 at Dose A in Study Part 2 — BIOLOGICAL
  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
  Administration of Dose B of ACI-24.060 in Study Part 2
• ACI-24.060 at Dose C in Study Part 2 — BIOLOGICAL
  Administration of Dose C of ACI-24.060 in Study Part 2
• Placebo (Study Part 1b) — BIOLOGICAL
  Administration of Placebo in Study Part 1b
• ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b — BIOLOGICAL
  Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b

Study Details

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.

Key Dates

Start date

Jun 21, 2022

Status verified

May 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

304 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo for Study Part 1a (Prodromal AD)
  Prodromal AD participants receive placebo at predefined time points over 48 weeks
• Experimental: ACI-24.060 at Dose A in Prodromal AD
  Prodromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks
• Experimental: ACI-24.060 at Dose B in Prodromal AD
  Prodromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks.
• Experimental: ACI-24.060 at Dose C in Prodromal AD
  Prodromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks.
• Experimental: ACI-24.060 with an additional adjuvant at Dose D in Prodromal AD
  Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose D at predefined time points over 74 weeks.
• Placebo Comparator: Placebo for Study Part 2 (Down syndrome)
  Participants with Down syndrome receive placebo at predefined time points over 74 weeks
• Experimental: ACI-24.060 at Dose A in Down syndrome
  Participants with Down syndrome receive dose A of ACI-24.060 at predefined time points over 74 weeks. Dose A will be a dose already tested in Study Part 1.
• Experimental: ACI-24.060 at Dose B in Down syndrome
  Participants with Down syndrome may optionally receive a dose B of ACI-24.060 at predefined time points over 74 weeks.
• Experimental: ACI-24.060 at Dose C in Down syndrome
  Participants with Down syndrome receive dose C of ACI-24.060 at predefined time points over 74 weeks. Dose C will be a dose already tested in Study Part 1.
• Experimental: ACI-24.060 with an additional adjuvant at Dose E in Prodromal AD
  Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose E at predefined time points over 74 weeks.
• Placebo Comparator: Placebo for Study Part 1b (Prodromal AD)
  Prodromal AD participants receive placebo at predefined time points over 74 weeks

Primary Outcome Measure

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) ]

Central Contacts

• Olivier Sol, MD
  +41 21 345 9121
  [email protected]
• Benedicte Le
  +41 21 345 9121
  [email protected]

Locations (13)

Find similar trials in Phoenix, AZ

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