Le Quesnoy

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Researchers are evaluating the safety of the SECURIDRAP4 SELFIA4 bedding system in adults with disorientation, cognitive impairment, or behavior disorders. This interventional, multicenter, prospective, and non-comparative clinical investigation takes place in nursing homes and hospitals in France. It was initiated following the market withdrawal of the first version of the product and is conducted to confirm the safety of the second version as recommended by the ASNM. Participants will use the SECURIDRAP4 SELFIA4 restraint system for 15 consecutive nights as part of their usual care. An independent assessor will monitor the proper use of the bedding system during this period to ensure compliance with safety conditions. The study focuses on adverse events linked to the product, user errors, patient bedridden status, healthcare team satisfaction, and the learning curve for proper use. During the 15-night follow-up, patients will be closely observed, and data on adverse events and user-related safety issues will be collected. Healthcare teams will provide feedback on time savings, comfort, well-being, and respect for patient dignity. The study tracks the rate of patients remaining bedridden each night and monitors the staffs ability to learn the proper use of the SECURIDRAP4 SELFIA4 system. The total participation duration is 15 nights with minimal risks and constraints.