NCT05569083: PREVIEW

PRedicting the EVolution of SubjectIvE Cognitive Decline to Alzheimer's Disease With Machine Learning

Status unknown Last updated 7 October 2022

What this trial tests

trial testing Genetic analysis of APOE and BDNF genes. in Cognitive Decline in 350 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
30 September 2023

30 March 2024

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria Careggi
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	350
Start date	1 October 2020
Primary completion	30 September 2023
Estimated completion	30 March 2024
Sites	4 locations across Italy

Drugs / interventions tested

• Genetic analysis of APOE and BDNF genes.
• EEG recording
• CSF collection and AD biomarker measurement
• Neuropsychological evaluation
• Assessment of cognitive reserve, depression, personality traits and leisure activities
• Clinical-neuropsychological follow-up
• ERP recording

Conditions studied

• Cognitive Decline — all drugs for Cognitive Decline →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Azienda Ospedaliero-Universitaria Careggi — full company profile →

Who can join

Eligibility, any sex, with Cognitive Decline or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Alzheimer's disease (AD) has a presymptomatic course which can last from several years to decades. Identification of subjects at an early stage is crucial for therapeutic intervention and possible prevention of cognitive decline. Current research is focused on identifying characteristics of the early stages of AD and several concepts have been developed to that end.

Subjective cognitive decline (SCD) is defined as a self-experienced persistent decline in cognitive capacity in comparison with the subject's previously normal status, during which the subject has normal age-, gender-, and education-adjusted performance on standardized cognitive tests. SCD is not related to current cognitive impairment, however it has been considered for its potential role as risk factors for AD.

The aim of this study is to evaluate, through machine learning tools, the accuracy data, neuropsychological assessment, personality traits, cognitive reserve, genetic factors, cerebrospinal fluid (CSF) neurodegeneration biomarkers, EEG and Event Related Potential recordings in predicting conversion from SCD condition, to Mild Cognitive Impairment (MCI) and AD.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PRedicting the EVolution of SubjectIvE Cognitive Decline to Alzheimer's Disease With machine learning: the PREVIEW study protocol.
   Mazzeo S, Lassi M, Padiglioni S, Vergani AA, et al · · 2023 · cited 18× · PMID 37573339 · DOI 10.1186/s12883-023-03347-8
2. Personalized modeling of Alzheimer's disease progression estimates neurodegeneration severity from EEG recordings.
   Amato LG, Vergani AA, Lassi M, Fabbiani C, et al · · 2024 · cited 13× · PMID 38371358 · DOI 10.1002/dad2.12526
3. Will artificial intelligence widen the therapeutic gap between children and adults?
   Nagy M, Sisk B, Lai A, Kodish E. · · 2024 · cited 11× · PMID 38516139 · DOI 10.1002/ped4.12407
4. Event-related potential markers of subjective cognitive decline and mild cognitive impairment during a sustained visuo-attentive task.
   Vergani AA, Mazzeo S, Moschini V, Burali R, et al · · 2025 · cited 7× · PMID 40023055 · DOI 10.1016/j.nicl.2025.103760
5. Digital twins and non-invasive recordings enable early diagnosis of Alzheimer's disease.
   Amato LG, Lassi M, Vergani AA, Carpaneto J, et al · · 2025 · cited 6× · PMID 40450374 · DOI 10.1186/s13195-025-01765-z
6. Gender differences in cognitive reserve: An impact on progression in subjective cognitive decline?
   Giacomucci G, Moschini V, Ceccarelli A, Padiglioni S, et al · · 2025 · cited 2× · PMID 40881583 · DOI 10.1002/dad2.70174
7. Personalized brain models link cognitive decline progression to underlying synaptic and connectivity degeneration.
   Amato LG, Vergani AA, Lassi M, Carpaneto J, et al · · 2025 · cited 2× · PMID 40188185 · DOI 10.1186/s13195-025-01718-6
8. EEG recordings during visuo-attentive task reduce sex bias in Alzheimer's disease diagnosis.
   Amato LG, Lassi M, Grippo A, Moschini V, et al · · 2026 · PMID 41953573 · DOI 10.1002/trc2.70245