A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early 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

15 Apr 2021 → 4 Mar 2026

Decision date (initial)

2022-11-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-501188-42-00

EudraCT number

2020-000116-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Pharmacogenomic, Efficacy, Others, Pharmacodynamic, Safety

The primary objective is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the iADRS, a composite of cognition and function

Secondary objectives 6

1. To evaluate the effect of JNJ-63733657 versus placebo on cognitive decline as measured by the ADAS-Cog13
2. To evaluate changes in functional status between participants treated with JNJ-63733657 versus placebo as measured by the ADCS-ADL-MCI
3. To evaluate the effect of JNJ-63733657 compared with placebo on cognitive as decline, as measured by the RBANS Total Scale Index Score
4. To evaluate the effect of JNJ-63733657 on clinical progression compared with placebo as measured by CDR-SB
5. To evaluate the effect of JNJ-63733657 on the accumulation and/or propagation of tau pathology compared with placebo, as measured by tau PET
6. For other secondary objectives, please refer to the protocol

Conditions and MedDRA coding

Early Alzheimer's Disease

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

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/transparency. 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. 55 to 80 years of age, inclusive, at the time of initial consent.
2. 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.
3. Evidence of pathologic tau on a screening tau PET scan reviewed centrally by a qualified reader, as prespecified in a separate Imaging Charter.
4. 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
5. For other inclusion criteria, please refer to the protocol

Exclusion criteria 6

1. Participants with CDR-GS ≥2 at predose baseline CDR administration.
2. 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).
3. GDS-30 score >12.
4. HIS >4.
5. Known carriers of a Presenilin 1 (PSEN1), PSEN2, or Amyloid Precursor Protein mutation associated with Autosomal Dominant AD or any other neurodegenerative disease.
6. For other exclusion criteria, please refer to the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline on the iADRS total score at week 104

Investigational products

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

Test 2

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 13

Locations

5 EU/EEA countries · 31 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

Urgent safety measures 2 · Art. 54 CTR

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

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

Documents 65 files

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

Application history

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