The ICOD project is structured in different specific aims so that different teams develop different components of the project.
Project management & coordination
The first specific aim led by IMIM (Dr. de la Torre) will manage the project to guarantee quality, and coordinate accessibility of the data generated ensuring data security and proper management of intellectual property. The Project Management and the ICOD Dissemination Board will oversee the communication plan to ensure that information reaches the target audience: the general public, the press, the public institutions, the medical & scientific community, the Down syndrome (DS) community, the pharmaceutical industry and investors.
Preclinical activities specifically designed for the need of Down subjects
The goal of this specific aim led by Aelis Farma is to interact with regulatory authorities in order to obtain Phase I clinical trial authorizations and scientific advice and perform complementary ADMET and CMC developments needed for Phase II clinical trials.
Phase I studies in healthy volunteers and subjects with DS
The goal of this specific aim led by IMIM is to perform a Phase I study evaluating safety, tolerability and pharmacokinetic of AEF0217 in healthy volunteers and another Phase I study evaluating safety, tolerability and pharmacokinetic of AEF0217 in adult subjects with DS.
Phase II in individuals with DS
The goal of specific aim 4 led by IMIM is to assess the efficacy, safety and tolerability of AEF0217 in subjects with DS by executing two subsequent tasks:
Perform a non-interventional, usability and training study for the raters of this multicenter study site on the tools that will be used to evaluate subjects’ cognitive performance.
Perform a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase II dose-finding study evaluating the effects of AEF0217 on the cognitive performance of subjects with DS.
Dissemination and communication activities
The goal of this specific aim led by IRCCS Oasi Troina is to disseminate the results of the ICOD project to the scientific, clinical, business and pharma communities and to individuals with DS and their families as well as the general public. This will increase awareness on AEF0217, CB1-SSi and stimulate further research in the field of pharmacological treatments for cognitive impairment.
The objectives of specific aim 5 are threefold:
- Disclose new results.
- Raise awareness on their value and potential.
Promote the best use of the results and an active citizenship involvement in dissemination by incorporating subjects with DS and several general public initiatives in the framework of the dissemination of results.
The consortium will also put a public light on the project progress at each Down Syndrome Day (March 21st) during specific
This specific aim is led by Hospital de la Princesa and oversees all ethical aspects concerning ICOD research activities. Including:
- Review Information sheets and Informed consent forms for healthy subjects (Phase I studies) and DS subjects (Phase I multiple doses, Phase II studies).
- Development of specific tools for providing information to DS subjects in clinical studies (exploration of new picture-based ideas and brief videos).
- Involvement of DS subjects with parents/caregivers in co-creation focus meetings (design and discussion of explorations in Phase II).
- Ethical aspects related with the dissemination of results.