Alzheimer's Tau Platform: Regimen A - AADvac1
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-80
SponsorPaul S. Aisen
About this trial
The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.
Regimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).
Disqualifiers
No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).
Trial design
Design model
Parallel
Treatments tested in this trial
AADvac1
DrugSubcutaneous injection of AADvac1
Donanemab
DrugActive comparator: intravenous infusion of donanemab
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: AADvac1 monotherapyExperimental treatment 1 intervention
Group B: Combination AADvac1 therapy with donanemabExperimental treatment 2 interventions
Group C: Donanemab active controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
To determine whether at least one tau therapy, either alone or in combination with donanemab, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to donanemab alone.
Time frame
0, 6, 18 and 30 monthsSecondary outcomes
1
Disease progression as measured by plasma biomarkers
To assess whether at least one tau therapy, either alone or in combination with donanemab, slows disease progression as measured by plasma biomarkers.
Time frame
30 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Paul S. Aisen
Lead sponsor
University of Southern California
Sponsor institution
Axon Neuroscience SE
Collaborator
University of California, San Francisco
Collaborator
Massachusetts General Hospital
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
Alzheimer's Clinical Trials Consortium
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: