An interventional study of blood sampling in Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease and Alzheimer's Disease Dementia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
Among 10 studies in Cognitive Dysfunction by Fondazione Policlinico Universitario Agostino Gemelli IRCCS — 5 open to participants now, 7 under way, none of them phase 3. Cognitive Dysfunction · Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Among the 10 studies in Cognitive Dysfunction by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, this one is one of 2 that started in 2026, is one of 5 with no phase, and was the 9th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →5 of the 10 studies in Cognitive Dysfunction by Fondazione Policlinico Universitario Agostino Gemelli IRCCS are open now, in 1 country. Recruiting first, the newest first:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
By country, each count listing its studies:
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 55 Years to 80 Years · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 48 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 36 across the 5 interventional studies, 205 across the 5 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
1 of the studies in Cognitive Dysfunction by Fondazione Policlinico Universitario Agostino Gemelli IRCCS that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06896201Fondazione Policlinico Universitario Agostino Gemelli IRCCSComfortage - AD Prevention Strategies | 2027-03 |
Among the 10 studies in Cognitive Dysfunction by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This project aims to longitudinally profile plasma-derived GDEVs and plasma biomarkers of neuroinflammation across three stages of the AD continuum (Subjective Cognitive Decline, Mild Cognitive Impairment, and Alzheimer's Dementia), exploring their association with biomarkers of amyloidopathy, tauopathy and neurodegeneration, cognitive status and clinical outcome over time. Moreover, GDEVs - collected from subjects at different disease stages - will be used to treat human neurons derived from induced pluripotent stem cells (iPSCs) from healthy controls in order to assess the induced differential neurotoxic or priming effects. This dual translational approach may help identify early pathogenic signatures of neuroinflammation and elucidate their role in disease progression.
The primary goal of the project is to longitudinally profile plasma-derived GDEVs and neuroinflammation biomarkers to better understand their role in AD progression and to investigate novel, non-invasive blood-based biomarkers for improved diagnosis, prognosis, and disease monitoring.
The study will focus on key stages of the AD continuum, investigating the relationship between neuroinflammation and established indicators of core AD pathology, cognitive decline, and clinical progression over time.
An innovative dual translational approach will test the effects of disease-stage-specific GDEVs on healthy human iPSC-derived neurons, assessing their neurotoxic or priming effects and revealing their direct biological impact. This combined approach aims to identify early neuroinflammation signatures and investigate novel diagnostics and therapeutic targets.
A multidisciplinary approach will be adopted to achieve the following four objectives:
Objective 1: To profile changes in plasma-derived GDEV cargo and neuroinflammation biomarkers across the AD continuum, from cognitively normal individuals to those with SCD-AD, MCI-AD and Dem-AD.
Objective 2: To investigate the relationship between GDEVs/neuroinflammation biomarkers and fluid biomarkers of amyloidopathy, tauopathy, and neurodegeneration.
Objective 3: To assess their association with clinical and cognitive markers of AD progression, identifying biological profiles predictive of cognitive decline and clinical progression rate.
Objective 4: To assess the neurotoxic or priming effects of GDEVs from different disease stages on human iPSC-derived neurons from healthy subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single arm
Procedure: blood sampling
blood sampling for plasma biomarkers analyses
Longitudinal changes
Longitudinal changes in plasma-derived GDEV cargo and neuroinflammation biomarkers across the Alzheimer's disease continuum
Time frame: 24 months
Disease-stage-specific molecular signatures
Identification of disease-stage-specific GDEV molecular signatures associated with progression along the AD continuum
Time frame: 24 months
Associations between biomarkers
Identification of associations between GDEV/neuroinflammation biomarkers and established fluid biomarkers of amyloidopathy, tauopathy and neurodegeneration
Time frame: 24 months
Relationships with Clinical Measures
Evaluation of the rate of correlations between plasma GDEV profiles and clinical measures of disease severity, including global cognitive performance, domain-specific cognitive decline, functional impairment and clinical staging (evalauted through neuropsychological assessments and clinical scales)
Time frame: 24 months
Predictive Value
Exploration of the predictive value of baseline and longitudinal GDEV/neuroinflammation profiles in predicting clinical progression along the AD continuum
Time frame: 24 months
Neurotoxic or priming effects
Assessment of the prevalence of neurotoxic or priming effects of GDEVs from different disease stages on human iPSC-derived neurons from healthy subjects, comparing the biological effects of GDEVs across disease stages
Time frame: 24 months
Plan to share: No — Privacy
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2028, 24 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →