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Comfortage - AD Prevention Strategies | Clinical Trials | Clareo Health

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Comfortage - AD Prevention Strategies

Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies

NCT06896201•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Study is Interventional, cross-sectional, clinical trial without drug and without device

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 1, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

August 26, 2025

Enrollment

200

ESTIMATED participants

Conditions

Alzheimer DiseaseSubjective Cognitive ImpairmentMild Cognitive Impairment

Interventions

Neuropsychological Assessments and Other Questionnaires

DIAGNOSTIC_TEST

Blood Exams, Fluid Biomarkers, Genetics

BIOLOGICAL

Connectivity Analysis

OTHER

Physical Activity

DEVICE

Healthentia

DEVICE

Eligence

DEVICE

Nutrition

OTHER

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

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RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comfortage - AD Prevention Strategies

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases