Trials / Unknown
UnknownNCT06246019
The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers
The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers: the PLASMAR Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Hospital del Mar Research Institute (IMIM) · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital. The main questions it aims to answer are: 1. Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit? 2. Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption? 3. Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption? 4. Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up? 5. Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit? Participants will be asked to: * Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study. * Complete specific scales in each visit. Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.
Detailed description
Blood-based biomarkers that accurately detect Alzheimer's disease (AD) and neurodegeneration now offer a realistic, cost-effective and non-invasive assessment that will aid the diagnostic process in patients presenting with cognitive clinical manifestations. Plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) have shown high diagnostic accuracy to detect AD, while plasma Neurofilament light chain (NfL) indicates neuronal injury. Despite these promising results, there is still no clear real-word evidence of their clinical applications. Here, the PLASMAR project aims to determine whether blood-based biomarkers have an impact on the clinical management of patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital, which provides care to a heterogeneous population. The project is divided into two specific objectives. First, the investigators will determine, in a research cohort, which blood biomarker or biomarkers' combination have the highest accuracy to detect AD. Second, a prospective clinical cohort of consecutive patients coming to the memory unit will be recruited. The investigators will assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit. Answering the question of whether blood-based biomarkers have a clinical impact in the real-world scenario of a memory unit, the PLASMAR project is crucial for the healthcare system and can guide the developing of guidelines and protocols on the use of blood-based biomarkers.
Conditions
- Alzheimer Disease
- Cognitive Impairment
- Dementia
- Neurodegenerative Diseases
- Frontotemporal Dementia
- Lewy Body Disease
- Vascular Dementia
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Early adoption of blood-based biomarkers for Alzheimer's disease | A blood test will be performed to obtain plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) and Neurofilament light chain (NfL) and results will be disclosure to the early and late arms at different time points. |
Timeline
- Start date
- 2024-02-07
- Primary completion
- 2025-05-01
- Completion
- 2025-12-31
- First posted
- 2024-02-07
- Last updated
- 2024-02-28
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06246019. Inclusion in this directory is not an endorsement.