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

The PLASMAR study at Hospital del Mar in Barcelona is an in-real-life look at how blood tests for Alzheimer’s-related markers could influence care. It is a randomized, 1-year study with about 200 adults who have memory or thinking concerns. Participants are assigned to have the blood test results told to their doctor early (at 3 months) or later (at 9 months). The study aims to see whether early results help clinicians reach a very high-confidence cause of symptoms, change how people are treated, affect anxiety and stress for patients and their caregivers, are acceptable and tolerable to patients, and whether using these biomarkers could save overall health care costs.

Who can join and what to expect: Adults aged 18 to 85 with reported cognitive or behavioral concerns, who can understand and give consent, may be eligible. Participants should have had or will have a brain scan (MRI or CT) as part of their standard workup, and if dementia is present, a study partner is needed. At the start you’ll have a blood draw and complete brief questionnaires at each visit about mood, stress, and quality of life. The study visits will last about a year, with outcomes focused on diagnostic confidence, changes in doctor recommendations, and overall experiences and costs of care. No experimental drugs are given, and there is no plan to share individual data in a way that would allow other researchers to access it.

Gender

ALL

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.