A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants with Preclinical Alzheimer’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

14 Jan 2025 → ongoing

Decision date (initial)

2024-10-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacodynamic, Safety, Efficacy, Pharmacogenomic

To explore the effect of JNJ-64042056 on the propagation and/or accumulation of tau pathology compared with placebo, as measured by tau positron emission tomography (PET) in specified regions of interest (ROIs) in the brain

Conditions and MedDRA coding

Preclinical Alzheimer’s Disease

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparecy. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. 55 to 75 years of age, inclusive, at the start of screening.
2. 2. Elevated brain tau pathology defined as Braak 3 ROI SUVR > 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader, to enrich for probability of disease progression during the study.
3. 3. CDR global score of 0 at screening and baseline.
4. 4. MMSE ≥27 (with educational adjustment) at screening.
5. 5. Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening.

Exclusion criteria 5

1. 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. 2. History consistent with or known autosomal dominant AD.
3. 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. 4. Diagnosis ofMild Cognitive Impairment (MCI)
5. 5. Presence of any neurological, psychiatric, or medical conditions associated with a longterm risk of significant cognitive impairment or dementia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in brain tau burden, as measured by tau PET in specified ROIs (including but not limited to Braak I-VI ROIs, Tau Naïve Composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 14

Locations

5 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 5 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 152 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications