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2022-501188-42-00CompletedPhase 2

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

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Dec 2025

Next steps

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
195 (actual)
First submitted
1 Sept 2022
Start date
15 Apr 2021
Lead sponsor
Janssen - Cilag International
EU CT number
2022-501188-42-00
EudraCT number
2020-000116-30

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 195
  • 30 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Az St-Jan Brugge-Oostende A.V.BruggeBelgiumCompleted
Antwerp University HospitalEdegemBelgiumCompleted
Universiteit GentGentBelgiumCompleted
JESSA ZiekenhuisHasseltBelgiumCompleted
UZ BrusselJetteBelgiumCompleted
UZ LeuvenLeuvenBelgiumCompleted
AZ DeltaRoeselareBelgiumCompleted
Cliniques Universitaires Saint-LucSint-Lambrechts-WoluweBelgiumCompleted
Hospital del MarBarcelonaSpainCompleted
Fundació ACE, Institut Català de Neurociències AplicadesBarcelonaSpainCompleted
Hospital de la Santa Creu i Sant PauBarcelonaSpainCompleted
Oroitu S.L.GetxoSpainCompleted
Hospital Universitari de Santa MariaLleidaSpainCompleted
Fundacion Para La Investigacion Biomedica Del Hospital Clinico San CarlosMadridSpainCompleted
Hospital Universitari General de CatalunyaSant Cugat del VallèsSpainCompleted
Fundacio Assistencial De Mutua De TerrassaTerrassaSpainCompleted
Hospital Universitario Y Politecnico La FeValenciaSpainCompleted
Pellegrin HospitalBordeauxFranceCompleted
Centre Hospitalier Universitaire De LilleLille CedexFranceCompleted
Assistance Publique Hopitaux de ParisParisFranceCompleted
Centre Hospitalier Universitaire de RennesRennesFranceCompleted
CHU De RouenRouen CedexFranceCompleted
Centre Hospitalier Universitaire de NantesSaint-HerblainFranceCompleted
Centre Hospitalier Universitaire de ToulouseToulouseFranceCompleted
Centre Hospitalier Régional Universitaire de ToursToursFranceCompleted
Brain Research Center Amsterdam B.V.AmsterdamNetherlandsCompleted
Universitair Medisch Centrum GroningenGroningenNetherlandsCompleted
Brain Research Center Den Bosch B.V.'s-HertogenboschNetherlandsCompleted
Brain Research Center Zwolle B.V.ZwolleNetherlandsCompleted
Karolinska University HospitalHuddingeSwedenCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.