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Search / Trial NCT06856681

Clinical Utility of Early Vs. Late Blood Biomarker Testing for Alzheimer's Disease

Launched by C2N DIAGNOSTICS · Feb 26, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Blood Biomarkers Mild Cognitive Impairment Dementia Alzheimers Disease

ClinConnect Summary

This clinical trial is looking at the use of a blood test called PrecivityAD2 to help diagnose Alzheimer's disease more quickly. The main question is whether getting the test results early, along with some additional testing, can speed up the time it takes to find out if someone has Alzheimer's or another condition, compared to waiting for the results. Participants will be divided into two groups: one will receive their test results right away, while the other will get them later. The study will last for one year, and participants will visit the clinic several times during that time. There is also an option for participants and their caregivers to share their experiences through questionnaires.

To be eligible for the study, participants need to be at least 50 years old and show signs of memory or thinking problems that could be related to Alzheimer's disease. They should be able to attend study visits and provide blood samples for testing. However, people younger than 50 or those with other known causes of cognitive impairment won’t qualify. This study aims to help improve how we diagnose Alzheimer's, making it easier for patients and their families to get the answers they need.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Minimum age: 50 years.
  • 2. Patients presenting with symptoms of mild cognitive impairment (MCI) or other cognitive impairments in which the enrolling clinician clinically suspects Alzheimer's pathology as the primary cause of symptomatic presentation
  • 3. Patients presenting with mixed brain pathologies including MCI/ cognitive impairments in which the investigator clinically suspects Alzheimer's pathology as the primary or contributing cause of symptomatic presentation
  • 4. Patients are able to attend study visits and standard care visits over the period of 1 year from the date of enrollment
  • 5. Patients are able to undergo routine phlebotomy and provide up to six (6) 10 ml tube(s) of blood for study related tests plus any additional blood necessary for standard laboratory testing at each study timepoint
  • 6. Patients are able to undergo standard care diagnostic procedures to include MRI (or CT), amyloid PET and/or CSF biomarker testing for AD diagnosis if prescribed by investigator
  • 7. Patients are able to provide informed consent. Or, if in the opinion of the clinician, the patient is unable to adequately understand the nature of the trial and protocol requirements, a family member or appropriate representative of the patient is present to consent, with additional assent by the patient.
  • Exclusion Criteria
  • 1. Patients younger than 50 years of age
  • 2. Patients being evaluated for cognitive impairment known to be predominantly the result of a disease or condition other than AD
  • 3. Patients previously diagnosed with AD, unless the ADELAIDE investigator has a strong clinical suspicion suggestive of an incorrect initial diagnosis upon referral
  • 4. Patients with no cognitive impairment or clinical symptoms of AD
  • 5. Patients desiring genetic testing for Alzheimer's disease markers without current cognitive impairment or other relevant clinical symptoms
  • 6. Patients who are not able or not willing to undergo standard care diagnostic procedures to include MRI (or CT), amyloid PET and/or CSF biomarker testing for AD diagnosis as prescribed by investigator
  • 7. Patients who are not able to understand the nature of the study nor the study requirements and not represented by a family member or other appropriate representative who is able to consent on behalf of the patient
  • 8. Patients who are not able to commit to attending the required study and/or standard care visits
  • 9. Patients who are not able to undergo routine phlebotomy or provide blood samples in the quantity required by the study protocol

About C2n Diagnostics

C2N Diagnostics is a leading biotechnology company focused on advancing the understanding and diagnosis of neurodegenerative diseases, particularly Alzheimer’s disease. With a commitment to innovation, C2N develops proprietary diagnostic tests and biomarker solutions that enable earlier and more accurate detection of these conditions. The company leverages cutting-edge research and technology to enhance patient care and facilitate targeted therapeutic interventions. By collaborating with academic institutions and industry partners, C2N Diagnostics aims to transform the landscape of neurological diagnostics and improve outcomes for patients and their families.

Locations

Patients applied

0 patients applied

Trial Officials

Vice President, Neurology

Study Director

C2N Diagnostics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported