Comfortage - AD Prevention Strategies

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 19, 2025

Keywords

ClinConnect Summary

The Comfortage trial is a study aimed at understanding strategies for preventing Alzheimer’s disease and related cognitive decline. It focuses on individuals who may be experiencing early signs of memory issues, such as subjective cognitive impairment (where a person feels their thinking is not as sharp as it used to be) or mild cognitive impairment (where there is a noticeable decline in cognitive abilities but daily activities can still be performed independently). This study is open to adults aged 50 to 85 who can clearly communicate in Italian and who have not participated in other specific Alzheimer treatment trials.

Participants in the trial will be asked to share their experiences and undergo assessments to determine their cognitive abilities. It's important to note that this study does not involve any medications or devices; instead, it aims to gather valuable information about cognitive health. If you or a loved one fits the criteria and is interested, keep an eye out for when the study begins recruiting participants. Your involvement could contribute to important discoveries in Alzheimer’s prevention.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities
• • mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); Clinical Dementia Rating Scale = 0.5
• • Ability to sign and understand the informed consent form
• Exclusion Criteria:
• • Age under 50 or over 85 years
• • Non-native Italian speakers
• • Non degenerative and secondary forms of dementia
• • Previous or current participation in clinical trials with anti-amyloid agents