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
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
- Diseases
- Alzheimer disease
- 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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az St-Jan Brugge-Oostende A.V. | Brugge | Belgium | Completed |
| Antwerp University Hospital | Edegem | Belgium | Completed |
| Universiteit Gent | Gent | Belgium | Completed |
| JESSA Ziekenhuis | Hasselt | Belgium | Completed |
| UZ Brussel | Jette | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| AZ Delta | Roeselare | Belgium | Completed |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Hospital del Mar | Barcelona | Spain | Completed |
| Fundació ACE, Institut Català de Neurociències Aplicades | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Completed |
| Oroitu S.L. | Getxo | Spain | Completed |
| Hospital Universitari de Santa Maria | Lleida | Spain | Completed |
| Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos | Madrid | Spain | Completed |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Spain | Completed |
| Fundacio Assistencial De Mutua De Terrassa | Terrassa | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Pellegrin Hospital | Bordeaux | France | Completed |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris | Paris | France | Completed |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Completed |
| CHU De Rouen | Rouen Cedex | France | Completed |
| Centre Hospitalier Universitaire de Nantes | Saint-Herblain | France | Completed |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Completed |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Completed |
| Brain Research Center Amsterdam B.V. | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Completed |
| Brain Research Center Den Bosch B.V. | 's-Hertogenbosch | Netherlands | Completed |
| Brain Research Center Zwolle B.V. | Zwolle | Netherlands | Completed |
| Karolinska University Hospital | Huddinge | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.