A Clinical Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
- Conditions
- Early Alzheimer’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-000116-30-FR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 420
Each potential participant must satisfy these and all of inclusion criteria to be enrolled in the study:
• 55 to 80 years of age, inclusive.
• 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.
• 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
Any potential participant who meets these or any of the exclusion criteria will be excluded from participating in the study:
• Participants with CDR-GS =1 during screening or 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 =11.
• Rosen Modified 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.
• Medical instability or other causes for cognitive impairment that aren't AD
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the effect of JNJ-63733657 versus placebo on cognitive decline using the ADAS-Cog13;Secondary Objective: The secondary objects are: <br>• to evaluate the effect of JNJ-63733657 compared with placebo on cognitive decline: measured by the RBANS Total Scale Index Score<br>• to evaluate the effect of JNJ-63733657 compared with placebo on clinical progression: measured by CDR-SB<br>• to evluate changes in functional status between participants treated with JNJ-63733657 or placebo: measured by ADCS ADL MCI<br>• to evaluate the effect of JNJ-63733657 on the accumulation and/or propagation of tau pathology<br>compared with placebo: measured by tau PET<br><br><br>For other secondary objectives, please refer to the protocol.<br>;Primary end point(s): Change from baseline on the ADAS-Cog13;Timepoint(s) of evaluation of this end point: At screening, on Day 1 (D1), Week 24 (W24), W52, W76, W104, W128, W156, W180, W208, W232, Early termination (ET)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): a) Change from baseline on the RBANS Total Scale Index Score<br> b) Change from baseline on the CDR-SB<br> c) Change from baseline on the ADCS-ADL MCI<br> d) Change from baseline in brain tau burden, as measured by tau PET<br> <br>;Timepoint(s) of evaluation of this end point: a) At screening, W12, W36, W64, W88, W116, W140, W168, W192, W220, ET<br>b) At screening, D1, W24, W52, W76, W104, W128, W156, W180, W208, W232, ET<br>c) At D1, W24, W52, W76, W104, W128, W156, W180, W208, W232, ET<br>d) At screening, W52, W104, W156, W208, ET<br><br>