Muscle–brain connections in older adults with and without neurological disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares two groups of people aged 60 and older: a "good aging" group (low frailty, no general cognitive impairment, no sarcopenia) and a group with defined neurological disorders (ALS, Parkinson's disease, Alzheimer's disease, or severe acquired brain injury). Participants undergo clinical evaluations including frailty and cognitive testing together with neuromuscular assessments to characterize muscle–nerve function and the neuromuscular junction. The goal is to link clinical measures and neuromuscular findings to patterns associated with healthy aging versus neurodegeneration. Data are collected at multiple Italian centers to build a comparative picture of the muscle–brain axis in aging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

for Good aging group:

* Subjects aged 60 years or older
* Frailty Index below the pathological cut-off (\>0.25)
* Absence of general cognitive impairment (MMSE \> 24 points)
* Absence of a diagnosis of sarcopenia

for Bad aging group:

* Patients aged over 60 years
* Exclusive presence of one of the following diagnoses:

  1. Definite, probable, or probable laboratory-supported Amyotrophic Lateral Sclerosis (ALS), either sporadic or familial, according to the revised El Escorial Criteria for ALS diagnosis.
  2. Parkinson's disease (PD) according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., Mov Disord., 2015 Oct; 30(12): 1591-1601).
  3. Alzheimer's disease (AD), possible or probable, according to international diagnostic guidelines.
  4. Diagnosis of severe acquired brain injury according to the Italian Guidelines for the Care of Patients in Vegetative State and Minimally Conscious State 2011 (approved by the Unified Conference on May 5, 2011 - Ministry of Health, Italy), with the presence of Sarcopenia.
  5. Presence of Mild Cognitive Impairment (MCI), subjective memory complaint, or deficit in a single cognitive domain, according to international criteria and in absence of established neurological diseases and sarcopenia.
  6. Presence of Sarcopenia as defined by the EWGSOP2 Sarcopenia Consensus, in the absence of cognitive deficits and established neurological diseases.

Exclusion Criteria:

* Inability to provide informed consent.
* Presence of severe and/or acute comorbidities (e.g., uncontrolled diabetes, heart failure, or a diagnosis of oncological disease), as determined by the research team.
* Evidence of other previous neurological or psychiatric disorders involving the cognitive domain.
* Uncontrolled or complicated systemic diseases or history of traumatic brain injury.
* For subjects with Alzheimer's disease (AD), Parkinson's disease (PD), and Amyotrophic Lateral Sclerosis (ALS), individuals with a history of epilepsy will also be excluded.

Where it's running

• IRCCS Centro Neurolesi Bonino Pulejo
  Messina, Italy Recruiting
• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
  Milan, Italy Recruiting
• Universita degli Studi di Catania
  Catania, Italy Active not recruiting
• University of Roma La Sapienza
  Roma, Italy Active not recruiting

Study contacts

• Study coordinator: Christian Lunetta, MD
• Email: christian.lunetta@icsmaugeri.it
• Phone: +39 0250725266

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.