Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing AADvac1 for Preclinical Alzheimer's Disease
The goal of the Alzheimer's Tau Platform (ATP) is to measure the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are AADvac1, or Tau2. The registry lists allocation as randomized. The goal of the Alzheimer's Tau Platform (ATP) is to measure the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.
They plan to enroll about 900 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
The Alzheimer's Disease Tau Platform Clinical Trial
Interventions: AADvac1, Tau2
Primary outcome (registry wording): Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
Who it is for (from inclusion criteria)
Ages 50 Years to 80 Years
Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \<1.5
Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \<1.5)
MMSE score at screening of 20-30 (inclusive) with educational adjustments:
If \<12 years of education, MMSE required to be \>20
If 13 to 15 years (inclusive) of education, MMSE required to be \>22
If \>16 years of education, MMSE required to be \>24
Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD
Who the registry excludes
Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study
Lacks good venous access such that multiple blood draws would be precluded
Weighs less than 40kg, or more than 136kg at screening
Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen
Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received dummy treatment (placebo) in the previous study
Prior or current treatment with a prohibited medication as described per protocol
Enrollment in another investigational study as described per protocol. Participants enrolled in an watch-and-measure (no experimental treatment required) study may be permitted with Medical Monitor review and approval
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06957418?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06957418?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.