Brief 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).

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

12mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

3.4 years study duration

Study Progress72%

Feb 2024Jul 2027

Study Start

First participant enrolled

February 8, 2024

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2026

Completed

28 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2027

Expected

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

July 29, 2024

Last Update Submit

June 10, 2026

Conditions

Parkinson Disease Alzheimer Disease Mild Cognitive Impairment Dementia

Keywords

Endogenous and exogeneous risk factorsPrediction of disease progressionBiomarkersMagnetic Resonance Imaging (MRI)Quantitative Electroencephalography (qEEG)Vigilance and Sleep disorders

Outcome Measures

Primary Outcomes (5)

Predictivity in changes of RMN parameters
Changes in MRI-derived measures assess brain structural integrity, including white matter damage and the preservation of cortical networks. In detail, the following parameters will be measured: White matter lesions MRI cortical network volumes Default Mode Network (DMN) Dorsal Attention Network (DAN)
At patient's enrollment (Baseline)
Predictivity of EEG
Predictivity of changes in spectral power, measured using rsEEG sources, in detail: Power spectral density Delta band Theta band Alpha 1 band Alpha 2 band Beta 1 band Beta 2 band Gamma band
At patient's enrollment (baseline)
Predictivity of CFS and Blood derived Biomarkers
Measurement of Biomarkers in CFS and Blood samples. In particular, from CSF we will evaluate the following biomarkers: t-tau p-tau Aβ (Amyloid-beta) in blood samples we will evaluate: N-oxoaspartic acid N-acetylspermidine Methylselenopyruvate N-methylethanolamine phosphate Succinylacetone Capryloylglycine Acetylhistamine Androsterone Glutaric acid Cadaverine Quinolinic acid Maleylacetic acid N-methyladenosine D-erythrose L-cysteine Dethiobiotin Tetradecenoylcarnitine Beta-hydroxybutyric acid L-pyroglutamic acid Creatine Uric acid Propionylcarnitine Ophthalmic acid Homovanillic acid L-histidine L-serine phosphate Nicotinuric acid Diaminoadenosine L-methionine L-asparagine
At patient's enrollment (Baseline)
Predictivity of clinical parameters
The following clinical assessment tools will be used: Clinical assessment scales MDS-UPDRS Part III Beck Depression Inventory-II (BDI-II) Mini-Mental State Examination (MMSE) Montreal Cognitive Assessment (MoCA) Rey Auditory Verbal Learning Test - Immediate Recall (RAVLT Immediate) Rey Auditory Verbal Learning Test - Delayed Recall (RAVLT Delayed) Clock Drawing Test Semantic Fluency Test Phonemic Fluency Test Clinical and lifestyle variables Heart rate Physical activity Smoking status Hypertension Comorbidities (any additional disease) Body Mass Index (BMI)
At patient's enrollment (Baseline)
Predictivity of digital telemonitoring
By using electronic devices such as tablets and smartwatch we will assess parameters of cognitive function and quality of sleep. In details, by using specifically designed video games we will measured reaction time and accuracy of reaction. Quality of sleep will be recorded by wearing a smartwatch that will measure sleep duration, efficiency and quality. Interactive serious videogame response assessment Accuracy Reaction time Watch-derived measures Sleep duration Sleep efficiency Sleep quality Steps per day Intentional steps Incidental steps Average cadence during the best 30 minutes of the day
From enrollment to the end of telemonitoring at day 7

Study Arms (5)

healthy subjects

Diagnostic Test: Neuropsycological assesmentRadiation: cerebral MRIOther: EEGBiological: Venous blood sample of 20mlBiological: Sample collection of exfoliated buccal mucosa

Alzheimer MCI

* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week.

Diagnostic Test: Neuropsycological assesmentRadiation: cerebral MRIOther: EEGBiological: Venous blood sample of 20mlBiological: Sample collection of exfoliated buccal mucosaDevice: Telemonitoring at home for 1 week

Alzheimer Dementia

* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Venous blood sample of 20ml; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week.

Parkinson Disease MCI

Parkinson Disease Dementia