A study of JNJ-64042056 in participants with preclinical Alzheimer's disease
- Conditions
- Preclinical Alzheimer’s DiseaseNervous System Diseases
- Registration Number
- ISRCTN78730935
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 498
1. 55 to 75 years of age, inclusive, at randomisation visit.
2. Elevated brain tau pathology defined as Braak 3 ROI SUVR > 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader.
3. CDR global score of 0 at screening and baseline.
4. MMSE =27 (with educational adjustment).
5. Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening.
1. MRI evidence of any brain disease or intracranial pathology other than potential very early signs of AD or typical age-related changes, which in the opinion of the investigator or the central imaging reader and/or the sponsor, may affect cognition.
2. History consistent with or known autosomal dominant AD.
3. Fulfills diagnostic criteria for Alzheimer’s Dementia or non-Alzheimer’s Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson’s dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy.
4. Diagnosis ofMild Cognitive Impairment (MCI)
5. Presence of any neurological, psychiatric, or medical conditions associated with a longterm risk of significant cognitive impairment or dementia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
- Secondary Outcome Measures
Name Time Method