Active — Not RecruitingNot Applicable

Biomarkers in Alzheimer's and Parkinson's Diseases for IA

Italy65 participantsStarted 2024-02-08

Plain-language summary

Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general motility, the sleep-wake cycle, genomic instability and possible DNA damage may correlate with (or predict) the clinical condition of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The subject must be over 60 years of age; * The Subject must have a full understanding of the Italian language; * The subject is available to participate in the phase telemonitoring. Exclusion criteria: * Inability to sign the informed consent; * Severe dementia; * Other concomitant diseases; * Inability to participate in study procedures; * Presence of arrhythmia, heart failure or previous heart attack, peripheral vascular disease or impaired circulation, valvular disease (diseases affecting the aortic valve), other diseases known conditions, end-stage renal disease (ESRD), diabetes, neurological disorders (e.g example, tremors), bleeding disorder or taking prescribed anticoagulants, tattoo(s) on the wrist where you will wear the Samsung Galaxy Watch, you will have an implanted pacemaker, a defibrillator implanted heart or other implanted electronic devices.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is actively enrolling but no longer recruiting new participants — is there any chance I could still be considered, or are there similar observational studies I could join instead?
2Since this trial is measuring biomarkers like cerebrospinal fluid, blood tests, MRI, and EEG to predict disease progression, what would any of those procedures actually involve for me, and are there risks I should know about — especially with a spinal tap for CSF collection?
3The trial is tracking digital telemonitoring alongside clinical and brain imaging measures — what does that remote monitoring look like day-to-day, and how much time or technology would it realistically require from me or a caregiver?
4Because this is an observational biomarker study rather than a treatment trial, it wouldn't change my current care directly — so would you still recommend I pursue standard treatment options at the same time, and how would this study fit alongside that?
5The study covers Parkinson's, Alzheimer's, and mild cognitive impairment together — given my specific diagnosis, do you think my data would be particularly useful to this research, and what, if anything, might I learn about my own condition from participating?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictivity in changes of RMN parameters

Timeframe: At patient's enrollment (Baseline)

Predictivity of EEG

Timeframe: At patient's enrollment (baseline)

Predictivity of CFS and Blood derived Biomarkers

Timeframe: At patient's enrollment (Baseline)

Predictivity of clinical parameters

Timeframe: At patient's enrollment (Baseline)

Predictivity of digital telemonitoring

Timeframe: From enrollment to the end of telemonitoring at day 7

Trial details

NCT IDNCT07651085

SponsorIRCCS San Raffaele Roma

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-19

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Predictivity in changes of RMN parameters

Timeframe: At patient's enrollment (Baseline)

Predictivity of EEG

Timeframe: At patient's enrollment (baseline)

Predictivity of CFS and Blood derived Biomarkers

Timeframe: At patient's enrollment (Baseline)

Predictivity of clinical parameters

Timeframe: At patient's enrollment (Baseline)

Predictivity of digital telemonitoring

Timeframe: From enrollment to the end of telemonitoring at day 7