NCT06783010

Brief Summary

There is now strong scientific literature showing a relationship between sensory loss and cognitive performance and between sensory loss and incident dementia. We take as our starting point that people with hearing, vision, and/or cognitive problems have poorer health outcomes, possibly due to due to common age-related mechanism(s), iatrogenic problems in the health care system (e.g., misdiagnosis), and/or the decay of social networks. With this evidence, our project will provide a better understanding of the relationship between sensory loss and cognitive loss in older adults with or at risk for dementia using objective technologies to measure sensory deficits that refer not only to vision loss, hearing loss, olfaction and taste but also to senses deemed atypical, i.e., nociception. In particular, the project aims:

  1. 1.To assess the specific association between different sensory measures (central and peripheral hearing loss, retinal abnormalities measured by OCT, smell and taste objective measures, chronic pain, and proprioception subjective and electrophysiological measures.
  2. 2.To develop a multi-dimensional score using sensory features and clinical and lifestyle variables to predict the different types of dementia (Alzheimer's Disease, Fronto-Temporal Dementia, and Vascular Dementia) at different stages (Mild Cognitive impairment and Normal Cognition).
  3. 3.To create a connectomic map of the MRI morphologic and dynamic features of the Dementia cases and their relationships with sensorial features, describing the patterns differences in respect to the normal cognition controls.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Keywords

artificial intelligencesensory impairmentscognitive impairments

Outcome Measures

Primary Outcomes (1)

  • cognitive decline

    every subject from MOCA 15.5-26 to a MOCA score lower than 15.5

    36 months

Study Arms (4)

controls

normal hearing and cognitive

case_1

only with cognitive impairment (MOCA lower than 17.5)

case_2

subjects with a central auditory processing disorder and cognitive impairment (MOCA lower than 17.5)

case_3

subjects with a central auditory processing disorder diagnosis

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

older adults (over 65 years of age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Sardone R, Castellana F, Bortone I, Lampignano L, Zupo R, Lozupone M, Griseta C, Dibello V, Seripa D, Guerra V, Donghia R, Logroscino G, Solfrizzi V, Quaranta N, Ferrucci L, Giannelli G, Panza F. Association Between Central and Peripheral Age-Related Hearing Loss and Different Frailty Phenotypes in an Older Population in Southern Italy. JAMA Otolaryngol Head Neck Surg. 2021 Jun 1;147(6):561-571. doi: 10.1001/jamaoto.2020.5334.

  • Sardone R, Battista P, Donghia R, Lozupone M, Tortelli R, Guerra V, Grasso A, Griseta C, Castellana F, Zupo R, Lampignano L, Sborgia G, Capozzo R, Bortone I, Stallone R, Fiorella ML, Passantino A, Giannelli G, Seripa D, Panza F, Logroscino G, Quaranta N. Age-Related Central Auditory Processing Disorder, MCI, and Dementia in an Older Population of Southern Italy. Otolaryngol Head Neck Surg. 2020 Aug;163(2):348-355. doi: 10.1177/0194599820913635. Epub 2020 Apr 21.

  • Panza F, Lozupone M, Sardone R, Battista P, Piccininni M, Dibello V, La Montagna M, Stallone R, Venezia P, Liguori A, Giannelli G, Bellomo A, Greco A, Daniele A, Seripa D, Quaranta N, Logroscino G. Sensorial frailty: age-related hearing loss and the risk of cognitive impairment and dementia in later life. Ther Adv Chronic Dis. 2018 Nov 9;10:2040622318811000. doi: 10.1177/2040622318811000. eCollection 2019.

  • Nadar MS, Jasem Z, Manee FS. The Cognitive Functions in Adults with Chronic Pain: A Comparative Study. Pain Res Manag. 2016;2016:5719380. doi: 10.1155/2016/5719380. Epub 2016 Dec 29.

  • Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

  • Gates GA, Gibbons LE, McCurry SM, Crane PK, Feeney MP, Larson EB. Executive dysfunction and presbycusis in older persons with and without memory loss and dementia. Cogn Behav Neurol. 2010 Dec;23(4):218-23. doi: 10.1097/WNN.0b013e3181d748d7.

  • Gadkaree SK, Sun DQ, Li C, Lin FR, Ferrucci L, Simonsick EM, Agrawal Y. Does Sensory Function Decline Independently or Concomitantly with Age? Data from the Baltimore Longitudinal Study of Aging. J Aging Res. 2016;2016:1865038. doi: 10.1155/2016/1865038. Epub 2016 Sep 27.

  • Brenowitz WD, Kaup AR, Yaffe K. Incident dementia and faster rates of cognitive decline are associated with worse multisensory function summary scores. Alzheimers Dement. 2020 Oct;16(10):1384-1392. doi: 10.1002/alz.12134. Epub 2020 Jul 12.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Francesco Panza, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

June 30, 2025

Primary Completion

June 30, 2025

Study Completion

January 10, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01