Le Quesnoy

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are conducting a multicenter, prospective, interventional clinical investigation in nine French healthcare establishments to assess the safety of the SECURIDRAP® SELFIA® bedding. This study follows the market withdrawal of the first version of this product and is carried out upon recommendation from the ASNM to evaluate the safety of the second version. The study involves patients with disorientation, cognitive impairment, or behavior disorders who have a medical prescription for the device. Participants will use the SECURIDRAP® SELFIA® bedding for 15 nights in real-life conditions within nursing homes and hospitals. During this time, an independent assessor will ensure that the device's usage conditions are properly followed. The study is interventional but non-comparative and is designed to pose minimal risks and constraints to participants. During the 15-night period, participants will be monitored for any adverse events related to the use of the SECURIDRAP® SELFIA®. Data collection will include safety evaluations to confirm the device's safe use in healthcare settings. The trial focuses on the occurrence rate of adverse events connected to the bedding's use, with close follow-up by researchers to ensure participant safety.