Tau Therapies for Alzheimer's Disease
(ATP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if new tau therapies, such as AADvac1 and Tau2, alone or combined with donanemab, can slow Alzheimer's disease by reducing harmful protein buildup in the brain. Participants will receive various treatment combinations to compare their effects on brain changes and memory. Individuals who have noticed memory issues related to Alzheimer's and have been diagnosed at an early stage might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that AADvac1 is safe and well-tolerated. Most participants experienced only mild reactions, such as redness or swelling at the injection site. Serious side effects were rare, occurring in about 17.1% of those treated. Notably, both the treatment and placebo groups reported similar numbers of side effects, indicating that AADvac1 is quite safe.
For the investigational treatment Tau2, clear safety data is limited. Since this trial is in Phase 2, Tau2 has already passed initial safety testing in earlier phases. This phase focuses more on efficacy while still monitoring safety. Overall, the safety of these treatments appears promising based on the available evidence.12345Why are researchers excited about this trial's treatments?
Unlike the standard Alzheimer's treatments, which mainly target amyloid proteins, AADvac1 and Tau2 focus on tau proteins, offering a fresh approach to managing the disease. AADvac1 is a vaccine that stimulates the immune system to attack abnormal tau proteins, potentially slowing disease progression. Tau2, on the other hand, acts as a monotherapy or in combination with donanemab to stabilize tau structures in the brain. Researchers are excited about these treatments because they target a different aspect of Alzheimer's pathology, which could lead to more comprehensive management of the disease.
What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?
Research has shown that AADvac1, a treatment under study in this trial, might help reduce the buildup of tau proteins in the brain, which are linked to Alzheimer's disease. Earlier studies found AADvac1 to be safe and well-tolerated, with some evidence suggesting it could slow the disease's progression. Specifically, patients treated with AADvac1 demonstrated a decrease in abnormal brain structures and tau proteins. Meanwhile, Tau2, another treatment option in this trial, has shown promise in slowing memory and thinking problems in Alzheimer's patients. Studies have reported a significant slowdown in mental decline and lower tau levels with treatments like Tau2. Both treatments aim to target the buildup of tau proteins, a key factor in the progression of Alzheimer's.13678
Who Is on the Research Team?
Keith Johnson, MD
Principal Investigator
Massachusetts General Hospital (MGH), Harvard Medical School
Adam Boxer, MD, PhD
Principal Investigator
University of California, San Francisco (UCSF), Memory and Aging Center
Are You a Good Fit for This Trial?
This trial is for adults aged 50-80 who have early signs of Alzheimer's disease or mild memory problems, show evidence of amyloid and tau buildup in the brain, are living at home or in assisted living, and meet certain cognitive test scores based on their education level.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AADvac1
- Tau2
Trial Overview
The study tests new treatments targeting tau protein (AADvac1 now, Tau2 later), alone or with donanemab (an anti-amyloid drug), to see if they slow Alzheimer’s progression. Participants are randomly assigned to different treatment groups over about 30 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants are randomized to receive either Tau2 directed monotherapy, combination Tau2 with donanemab, or donanemab alone (active control)
Participants are randomized to receive either AADvac1, combination AADvac1 with donanemab, or donanemab alone (active control)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Paul S. Aisen
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Alzheimer's Clinical Trials Consortium
Collaborator
University of California, San Francisco
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
Massachusetts General Hospital
Collaborator
Citations
NCT01850238 | Safety Study of AADvac1, a Tau Peptide- ...
This first-time-in-man study is mainly designed to assess the safety and tolerability of AADvac1 in the treatment of Alzheimer's disease.
AADvac1
Secondary outcomes include disease progression on alternative scales, activities of daily living, clinical global impression of disease severity ...
Post hoc analysis of ADAMANT, a phase 2 clinical trial ... - PMC
The primary outcome was safety. The secondary outcomes were the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the Alzheimer's Disease ...
4.
alzheimer-europe.org
alzheimer-europe.org/news/results-phase-ii-adamant-trial-aadvac1-mild-alzheimers-disease-published-nature-aging?language_content_entity\u003denResults of Phase II ADAMANT trial of AADVac1 for mild ...
Results of a Phase I clinical trial of AADVac1 revealed that the treatment was safe and well-tolerated by participants, with a trend towards improved ...
AADvac1, an Active Immunotherapy for Alzheimer's ...
Treatment with AADvac1 resulted in reduction of neurofibrillary pathology and insoluble tau in their brains, and amelioration of their deleterious phenotype.
ADAMANT: a placebo-controlled randomized phase 2 ...
AADvac1 was safe and well tolerated (AADvac1 n = 117, placebo n = 79; serious adverse events observed in 17.1% of AADvac1-treated individuals ...
Safety and immunogenicity of the tau vaccine AADvac1 in ...
AADvac1 was deemed safe, with local injection-site reactions being the only adverse event linked to treatment; high titres of the desired IgG antibodies were ...
AADvac1
AADvac1 had a favorable safety profile. Initial results were announced in September of 2019 and showed that 98.2% of patients who were given ...
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