The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers

Launched by HOSPITAL DEL MAR RESEARCH INSTITUTE (IMIM) · Feb 3, 2024

Keywords

ClinConnect Summary

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 th...

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Eligibility criteria

• Inclusion Criteria:
• • Subjects ≥18 and ≤85 years old of any sex, gender, race or ethnicity.
• • Individuals interested in participating in the study who understand the procedures that will be performed.
• • The patient must have a complaint (reported by the patient or by a study partner/caregiver) of cognitive or behavioral impairment.
• • The patient must satisfy the clinical diagnostic criteria for subjective cognitive decline, mild cognitive impairment, or mild dementia (defined as a Global deterioration scale score equal to 4), and a neurodegenerative disease such as AD is considered in the differential diagnosis.
• • Agreement to undergo all the study procedures, complete all clinical visits according to protocol and capacity to give informed consent.
• • The patient has undergone (maximum 12 months ago) or will undergo a dementia blood workup and MRI and/or CT scan before V1.
• • In dementia patients, a study partner must be available for the duration of the protocol.
• Exclusion Criteria:
• • Any significant systemic illness or unstable medical condition that could make it difficult to comply with the protocol.
• • Medical contraindications for any of the study procedures.
• • Available AD's cerebrospinal fluid biomarkers levels or amyloid-PET at screening.
• • The patient comes to the Memory Unit for reasons other than cognitive or behavioral impairment.
• • Patients in which an etiological diagnosis is already made.
• • The patient is currently participating or has participated in a clinical trial with an investigational pharmaceutical product.
• • Women who are pregnant, planning to become pregnant, or lactating.