Status:

NOT_YET_RECRUITING

The Brain&Senses Study

Lead Sponsor:

University of Campania Luigi Vanvitelli

Collaborating Sponsors:

Ospedali Riuniti Marche Nord, Fano-Pesaro Hospital

Conditions:

Mild Cognitive Impairment

Alzheimer Disease

Eligibility:

All Genders

60-85 years

Brief Summary

The aim of this longitudinal observational study is to evaluate the impact of sensory deficits (smell, hearing and balance on cognitive decline and quality of life in the medium term (5 years)) on a p...

Detailed Description

Evaluation protocol Enrollment phase: the subjects will be recruited through recruitment at the Department of Neurology of the Fano hospital and the various associations supporting patients with cogn...

Eligibility Criteria

Inclusion

  • Patients between 60 and 85 years of age
  • in general good health
  • the absence of known severe psychiatric disorders
  • available to be included in the study and
  • to follow the 5-year follow-up.

Exclusion

  • Obstructive nasal problems
  • Previous endoscopic nose + paranasal sinus surgery
  • Chronic use of cortisone spray and/or systemic
  • Subjects with previous stroke and outcomes
  • Subjects with history of stroke in the last 3 years without outcomes
  • Head trauma in the last 24 months
  • Previous ear surgery
  • Patients who have been exposed to chemical agents without protection for work, e.g. carpenters
  • previous Covid with outcomes (olfactory, vestibular, auditory and cognitive "brain fog")

Key Trial Info

Start Date :

August 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2030

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06991816

Start Date

August 1 2025

End Date

June 30 2030

Last Update

May 28 2025

Active Locations (1)

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1

Vanvitelli ENT department

Naples, Campania, Italy, 80138