A Clinical Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease

Phase 1

• Conditions: Early Alzheimer’s Disease; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000116-30-SE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Each potential participant must satisfy these and all of inclusion criteria to be enrolled in the study:
• 55 to 80 years of age, inclusive, at the time of initial consent.
Type of Participant and Disease Characteristics
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315

Exclusion Criteria

Any potential participant who meets these or any of the exclusion criteria will be excluded from participating in the study:
• Participants with CDR-GS =2 at predose baseline CDR administration.
• 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).
• GDS-30 score >12.
• HIS >4.
• Known carriers of a Presenilin 1 (PSEN1), PSEN2, or Amyloid Precursor Protein mutation associated with Autosomal Dominant AD or any other neurodegenerative disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified