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Clinical Trials/EUCTR2020-000116-30-SE
EUCTR2020-000116-30-SE
Active, not recruiting
Phase 1

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease

Janssen-Cilag International NV0 sites420 target enrollmentDecember 14, 2020
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ConditionsEarly Alzheimer’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Early Alzheimer’s Disease
Sponsor
Janssen-Cilag International NV
Enrollment
420
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 14, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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