Trials / Completed
CompletedNCT04445831
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease
A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- AC Immune SA · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.
Conditions
- Alzheimer's Disease
- Cognitive Impairment
- Tauopathies
- Mild Cognitive Impairment
- Dementia
- Brain Diseases
- Central Nervous System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ACI-35.030 | Administration of a Low dose of ACI-35.030 |
| BIOLOGICAL | ACI-35.030 | Administration of a Medium dose of ACI-35.030 |
| BIOLOGICAL | ACI-35.030 | Administration of a High dose of ACI-35.030 |
| OTHER | Placebo | Administration of Placebo |
| BIOLOGICAL | JACI-35.054 | Administration of a Low dose of JACI-35.054 |
| BIOLOGICAL | JACI-35.054 | Administration of a Medium dose of JACI-35.054 |
Timeline
- Start date
- 2019-07-31
- Primary completion
- 2023-09-05
- Completion
- 2023-09-05
- First posted
- 2020-06-24
- Last updated
- 2025-02-14
- Results posted
- 2025-02-14
Locations
9 sites across 4 countries: Finland, Netherlands, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT04445831. Inclusion in this directory is not an endorsement.