* EXPLAIN-AD
Research type
Research Study
Full title
Exploratory Platform trial on Anti-Inflammatory agents in Alzheimer’s Disease (EXPLAIN-AD): A randomized, placebo controlled, multicenter platform study to evaluate the efficacy, safety, tolerability and pharmacokinetics of various anti-inflammatory agents in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease.
IRAS ID
210425
Contact name
Josephine Emer MacSweeney
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003966-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 27 days
Research summary
Alzheimer's disease (AD) is a terminal neurodegenerative disorder that is characterised by progressive loss of cognitive function and independence. There is increasing evidence that suggests that inflammation in the brain and nervous system is a key contributor in the development of AD. Anti-inflammatory treatments are those that bring down inflammation and swelling. The purpose of this study is to determine whether various anti-inflammatory agents have a safe and beneficial effect on memory and thinking abilities in people who have mild cognitive impairment or Alzheimer's disease aged 45 to 90 years of age. This study will also see if anti-inflammatory treatment has an effect on “biomarkers” in the body. Biomarkers are important biological ‘indicators’ which can be measured in samples taken from our bodies, such as blood and cerebrospinal fluid (CSF).
The first anti-inflammatory agent that will be investigated in this study is Canakinumab (ACZ885). Canakinumab (ACZ885) has been studied in mild asthma, psoriasis, gouty arthritis, rheumatoid arthritis, and in people with a history of previous heart attack and it is approved as a treatment for several diseases that are associated with inflammation in various body parts and organs.
Canakinumab (ACZ885) has not been studied in Alzheimer’s disease to date.All participants will need a reliable Study Partner/Caregiver to attend each visit with them, which will consist of approximately 11 visits to the Study Doctor over approximately 9.5 months. During the study visits, participants will have various blood samples taken, including; blood tests, spinal tap procedure known as a “lumbar puncture” and assessments of memory and thinking both during clinic visits and at home. Taking part in this research study may not benefit participants directly, but it may help Researchers learn new things that could help treat patients in the future.
The English lay summary will be available one year post global LPLV (07/03/2024). It will be available to PIs to share with patients and posted in the public domain on Novartis public website https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C14b8430613244e81c33d08dd6531d4c7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638777986874241019%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=jQsJDeqP5kuKtEJsv1mDHugNKKecZLZkdeYPLdK4Y%2BU%3D&reserved=0
REC name
London - Fulham Research Ethics Committee
REC reference
21/FT/0044
Date of REC Opinion
14 May 2021
REC opinion
Further Information Favourable Opinion