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Clinical trial on healthy volunteers: research into Down's Syndrome (ICOD Project). - Clinical trials with volunteers - Hospital del Mar Research Institute

Hospital del Mar Research Institute Hospital del Mar Research Institute

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Clinical trial on healthy volunteers: research into Down's Syndrome (ICOD Project).

What does the study involve?

Down's syndrome is the most common intellectual disability with a genetic origin, affecting more than 5 million people worldwide. Medical procedures have substantially increased the life expectancy of people with Down's syndrome. However, cognitive and behavioural deficits have a strong impact on their daily activities and there is no approved treatment to improve these deficits in individuals with Down's syndrome.   A new molecule has been developed , known as AEF0217, which has a very new mechanism of action, modulating the receptors in the brain that are related to the effects of cannabis (cannabinoid receptors). Studies in animal models that reproduce the cognitive deficits of people with Down's syndrome have shown that AEF0217 is effective in improving cognitive performance. However, no studies have yet been carried out in humans to demonstrate its tolerability or efficacy. In this project we will study, for the first time in healthy volunteers, whether the AEF0217 molecule is safe and well tolerated.

The study is divided into three parts (Part 1: Single Rising Dose; Part 2: Multiple Rising Doses; and Part 3: Interaction with food). 68 volunteers will be needed to carry out the three parts of the study. If you take part in one part of the study you will not be able to take part in another. Depending on the part of the study, it will last from 2 to 10 weeks.

If you are selected according to the criteria of the study protocol, you will be scheduled for a day at the IMIM Clinical Research Unit (CRU). A physical examination will be carried out, details of your medical history will be collected, your vital signs will be recorded and blood tests will be performed. A negative PCR test for SARS-COV-2 from the 72 hours prior to admission to the CRU will also be requested. Once selected, you may be treated with either the AEF0217 molecule or a placebo (a product similar to the one we studied, but without any active substance), on a random basis (like flipping a coin). You will have to stay in the CRU for at least two nights. You will also have to come in several times over the duration of the study for follow-up visits.

Clinical projects

<p>ICOD Study</p>

Inclusion criteria:

  • The study has been authorised by the Spanish Agency for Medicines and Health Products (Agencia Española de los Medicamentos y Productos Sanitarios; AEMPS) and will be carried out according to a protocol approved by the Ethics Committee for Research with Medicines at the Parc de Salud Mar (CEIm-PSMAR).
  • Volunteers must be healthy women and men aged between 18 and 55 years old and weighing between 50 and 100 kg.
  • If you would like to take part, we will do a telephone interview, before you come to the centre, to check that you do not have a disease or take any substances/medication that could interfere with the results of the study, and that are listed in the exclusion criteria.
  • For the study, you will need to spend a morning at the CRU to do the initial assessment and check that you meet the participation criteria. Depending on the part of the study, you will need to spend two nights in the CRU, as well as attend several follow-up visits afterwards.
Hospital del Mar Research Institute

Dr. Aiguader, 88, 08003 Barcelona
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Phone: 93 316 04 00 · Fax: 93 316 04 10

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