Recruiting soon

ATPAADvac1 and Anti-amyloid mAb for Early Alzheimer's Disease

What is being tested

AADvac1

+ Anti-amyloid Monoclonal Antibody (mAb)

Drug

Who is being recruted

Alzheimer Disease+9

+ Mental Disorders

+ Brain Diseases

From 50 to 80 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 2025

See protocol details

Summary

Principal SponsorPaul S. Aisen

Study ContactATP Recruitment and Retention (RER) Team

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2025

Actual date on which the first participant was enrolled.

The Alzheimer's Tau Platform (ATP) is conducting a study to explore new treatments for Alzheimer's disease, specifically focusing on therapies that target a protein called tau. This study is important for adults aged 50 to 80 who are in the very early stages of Alzheimer's. The goal is to find out if these tau-targeted treatments, alone or combined with another type of treatment targeting amyloid proteins, can be safe and effective. Alzheimer's disease affects memory and cognitive function, and finding new treatments could help improve the quality of life for those starting to experience symptoms. Participants in this study are randomly assigned to different treatment groups after joining the main study framework. One of the treatment groups, called Regimen A, involves testing the drug AADvac1 either on its own or combined with an anti-amyloid treatment. There is also a group that receives only the anti-amyloid treatment as a control. The study ensures that everyone has an equal chance of being placed in any of these groups, which helps researchers compare the effectiveness of the treatments. Participants do not choose their group; instead, they are randomly assigned to ensure unbiased results. The study aims to observe the safety and potential effects of these treatments on slowing or altering the progression of Alzheimer's disease.

Official TitleAlzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1

NCT07167966

Principal SponsorPaul S. Aisen

Study ContactATP Recruitment and Retention (RER) Team

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

375 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersPick Disease of the BrainTauopathiesFrontotemporal Lobar DegenerationFrontotemporal Dementia

Criteria

1 inclusion criteria required to participate

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).

1 exclusion criteria prevent from participating

No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Intravenous infusions of anti-amyloid mAb-matched placebo for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)

Group II

Experimental

Intravenous infusions of an anti-amyloid mAb for 6 months, combination anti-amyloid mAb and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)

Group III

Active Comparator

Intravenous infusions of an anti-amyloid mAb for 6 months, combination anti-amyloid mAb and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 75).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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Recruiting soonNo study centers