A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
Key facts
- Where
- Barcelona, Getxo, Lleida, Madrid, Sant Cugat del Vallès, Terrassa és Valencia, SpanyolországSee the 9 sites
- Phase
- 2. fázis
Where in Spanyolország
- Fundació ACE, Institut Català de Neurociències AplicadesBarcelona, SpanyolországNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországNo longer taking part
- Hospital del MarBarcelona, SpanyolországNo longer taking part
- Oroitu S.L.Getxo, SpanyolországNo longer taking part
- Hospital Universitari de Santa MariaLleida, SpanyolországNo longer taking part
- Fundacion Para La Investigacion Biomedica Del Hospital Clinico San CarlosMadrid, SpanyolországNo longer taking part
- Hospital Universitari General de CatalunyaSant Cugat del Vallès, SpanyolországNo longer taking part
- Fundacio Assistencial De Mutua De TerrassaTerrassa, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen - Cilag International
- Trial code
- EU 2022-501188-42-00
- Record updated
- 2025. december 16.
- Original description
The primary objective is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the iADRS, a composite of cognition and functionRead full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's Disease
The primary objective is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the iADRS, a composite of cognition and function
Inclusion: 55 to 80 years of age, inclusive, at the time of initial consent; Early AD: Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and CDR-GS of 0.5 and memory box score ≥0.5 at screening; Evidence of pathologic tau on a screening tau PET scan reviewed centrally by a qualified reader, as prespecified in a separate Imaging Charter; Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant; For other inclusion criteria, please refer to the protocol.
Exclusion: Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc); Known carriers of a Presenilin 1 (PSEN1), PSEN2, or Amyloid Precursor Protein mutation associated with Autosomal Dominant AD or any other neurodegenerative disease; Participants with CDR-GS ≥2 at predose baseline CDR administration; GDS-30 score >12; HIS >4; For other exclusion criteria, please refer to the protocol.