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Contact Information:

Dr Craig Ritchie
+44 131 353 0233
C.Ritchie@brainsciences.scot


Dr . Study Team
-
medinfo@its.jnj.com


Dr . Study Team
-
JanssenUKRegistryQueries@its.jnj.com


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Be Part of Research - Trial Details - A study of JNJ-64042056 in participants with preclinical Alzheimer's disease
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A study of JNJ-64042056 in participants with preclinical Alzheimer's disease

Recruiting

Open to: All Genders

Age: Adult

Bristol London London Southampton Southampton Oxford Bath - Edinburgh

Medical Conditions

Preclinical Alzheimer’s Disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Alzheimer’s disease (AD) is a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks. Preclinical AD begins long before any symptoms are clearly visible.
JNJ-64042056 is a *liposomal active immunotherapy* that helps the body to generate specific antibodies against pathological forms of the tau protein causing Alzheimer’s Disease (an antibody is a protein made in the body in response to foreign, or in our case unwanted substance).
*Liposomal active immunotherapy* - Liposome is a closed, circular lipid bilayer, which can carry drug solutions. Active immunotherapy helps the body’s immune system to generate a specific immune response against a disease or infectious agent.
The primary purpose of the study is to see how effective JNJ-64042056 is compared to placebo on cognitive decline.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

28 May 2024 02 Jul 2027

This study will consist of:
- a pre-screening phase (approximately 4 weeks)
- a screening period (up to 13 weeks prior to randomization)
- a double-blind treatment period (approximately 48 months)
- a post-treatment follow-up period (2 weeks)
The participants will be assigned by chance to 1 of 2 treatment groups: JNJ-64042056 or placebo.
JNJ-64042056 or placebo will be administered from Week 0 up to Week 180 through injection into the muscle.
Study assessments will include questionaries, vital signs, electrocardiogram (ECG), blood and urine lab safety (including coagulation, thyroid function, vitamin B12, folic acid), antibody assessments, biomarker assessments, magnetic resonance imaging (MRI), positron emission tomography (PET), physical and neurological examination.
Total study duration for each participant will be approximately 4 years.


This study will include participants of 55 to 75 years of age diagnosed with preclinical Alzheimer’s Disease.

You can take part if:



You may not be able to take part if:


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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB
  • Charing Cross Hospital
    Fulham Palace Road
    London
    W6 8RF
  • Southampton
    Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • Moorgreen Hospital
    Botley Road West End
    Southampton
    SO30 3JB
  • Warneford Hospital
    Warneford Lane Headington
    Oxford
    OX3 7JX
  • Rice - the Research Institute for the Care of Older People
    The RICE Centre Royal United Hospital Combe Park
    Bath
    BA1 3NG
  • Re:Cognition Health
    centres based in Bristol, Birmingham, Winchester, Plymouth, London and Guildford
    -
    -
  • Scottish Brain Sciences
    Gyleview House, 3 Redheughs Rigg, South Gyle
    Edinburgh
    EH12 9DQ

There is no established benefit to participants of this study. Based on scientific theory, taking JNJ-64042056 may slow Alzheimer’s Disease progression and delay symptom onset. However, this cannot be guaranteed because JNJ-64042056 is still under investigation as a treatment. Participation may help other people with preclinical AD in the future.
If participants are put into the placebo treatment group, they will not receive JNJ-64042056 and will only receive placebo during this study.
Participants may have side effects from the drugs or procedures (such as procedural pain during insertion of a needle) used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. Since JNJ-64042056 has only been given to a relatively small number of people thus far, all possible side effects and risks related to JNJ-64042056 are not known. As of today, JNJ‑64042056 has been found safe and well tolerated in a small number of people. No pattern of adverse events considered related to JNJ-64042056 has emerged to date, other than mild and self-limiting injection site reactions after intramuscular (muscle of the upper arm) administration, consisting of pain, redness and/or swelling and/or pruritus (itching) and/or induration (thickening and/or hardening of the skin), on one or more occasion.
The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
During the study, the sponsor may learn new information about JNJ-64042056. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimise the risk associated with taking part in the study, participants are frequently assessed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.

Dr Craig Ritchie
+44 131 353 0233
C.Ritchie@brainsciences.scot


Dr . Study Team
-
medinfo@its.jnj.com


Dr . Study Team
-
JanssenUKRegistryQueries@its.jnj.com



The study is sponsored by Janssen-Cilag International NV and funded by Janssen Pharmaceutica.



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Read full details for Trial ID: ISRCTN78730935

Or CPMS 58779

Last updated 04 June 2024

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