AUTONOMY

• Research type

  Research Study

• Full title

  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

• IRAS ID

  290966

• Contact name

  Richard Perry

• Contact email

  Richard.perry3@nhs.net

• Sponsor organisation

  Janssen

• Eudract number

  2020-000116-30

• Clinicaltrials.gov Identifier

  NCT04619420

• Duration of Study in the UK

  4 years, 4 months, 3 days

• Research summary

  Alzheimer’s disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis.

  Extracellular amyloid plaques and intracellular tau tangles are pathological hallmarks of AD. JNJ-63733657 binds to p-tau, and it is hypothesized that it will decrease tau spread and thereby slow cognitive decline as measured by the Alzheimer’s Disease Assessment Scale Cognitive subscale 13-item
  version (ADAS-Cog13) as compared with participants receiving placebo.

  No clinical benefit of treatment with JNJ-63733657 has been demonstrated to date, but the method of action indicates a potential for a clinically meaningful effect for participants treated in this study. This includes the potential to slow the underlying pathophysiology of AD and thereby slow its clinical course.

  For all enrolled participants, the study will consist of:
  - a 90-day (13 weeks) screening period
  - a variable double-blind treatment period of up to 4.5 years
  - a follow-up period of approximately 90 days

  After giving initial written informed consent, eligible participants will be assigned randomly to 1 of 3 treatment groups: 1 of 2 dosages of JNJ-63733657 (1000 or 3000 mg) or placebo at a ratio of 1:1:1

  This study will enroll approximately 420 participants with prodromal AD or mild AD dementia (Early AD), approximately 140 participants per treatment group.
  

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  21/LO/0396

• Date of REC Opinion

  26 Jul 2021

• REC opinion

  Further Information Favourable Opinion