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

NCT06856681 | Withdrawn

• 1 other identifier: 250
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate whether use of the PrecivityAD2 blood biomarker assay with early result disclosure along with discretionary Precivity-ApoE proteotype testing will shorten the time to Alzheimer's Disease or non-Alzheimer's diagnosis as compared to delayed result disclosure. Participants will be randomized into the early PrecivityAD2 blood biomarker test \& disclosure group (Cohort A) or to the later PrecivityAD2 blood biomarker test \& disclosure group (Cohort B) where blood samples will be collected and tested using the PrecivityAD2 test at Visit 1 (day 0) and Visit 2 (day 90). Participants will attend study visits for one year after their enrollment. An optional sub-study will be offered to collect information through questionnaires at each visit regarding participant's and their care-giver's experiences through the AD diagnostic journey.

Conditions

Alzheimers Disease

Keywords

Blood biomarkers; Mild Cognitive Impairment; Dementia; Alzheimers disease

Outcome Measures

Primary Outcomes (2)

• Time to achieve >=90% Diagnostic Confidence for AD or Non-AD

  Number of days from enrollment to achieving a diagnostic confidence score of \>=90% for AD or non-AD diagnosis (based on physician survey).

  From enrollment until diagnosis, with primary assessment at Visit 2 (Day 90) and Visit 3 (Day 180).

• Proportion of Patients with AD of Non-AD Diagnosis

  Proportion of patients with a confirmed AD or non-AD diagnosis with a diagnostic confidence score of \>=90%.

  Assessed at Visit 2 (Day 90) and Visit 3 (Day 180)

Secondary Outcomes (4)

• Time to Initiation or Modification of AD or Non-AD Therapy

  Measured from enrollment through Visit 4 (Day 365).

• Proportion of patients on AD or non-AD prescription

  Assessed at Visit 3 (150-210)

• Number and Type of Diagnostic Tests Ordered

  Evaluated cumulatively at Visit 2 (Day 90), Visit 3 (Day 180), and Visit 4 (Day 365)

• Change in Physician Diagnostic Confidence

  Collected at Enrollment/Baseline (Day 0), Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365)

Other Outcomes (3)

• Patient-Reported Experience with Diagnostic Process

  Collected at Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365)

• Caregiver-Reported Perception of Disease Burden

  Collected at Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365)

• Healthcare Utilization and Costs

  Enrollment through Visit 4 (Day 365)

Study Arms (2)

Early Testing Group (Cohort A)

EXPERIMENTAL

Participants in this group will have blood drawn from the PrecivityAD2 test at Visit 1 (Day 0). Physicians will use these results in clinical decision-making from that point forward.

Diagnostic Test: PrecivityAD2 - Early Testing

Delayed Testing Group (Cohort B)

EXPERIMENTAL

Participants in this group will have blood drawn for the PrecivityAD2 test at Visit 2 (Day 90). Until then, standard clinical decision-making will process without access to PrecivityAD2 results.

Diagnostic Test: PrecivityAD2 - Delayed Testing

Interventions

PrecivityAD2 - Early Testing DIAGNOSTIC_TEST

Participants in Cohort A will receive PrecivityAD2 testing at Visit 1, with results disclosed shortly after testing.

Early Testing Group (Cohort A)

PrecivityAD2 - Delayed Testing DIAGNOSTIC_TEST

Participants in Cohort B will receive PrecivityAD2 testing at Visit 2, with results disclosed shortly after testing.

Delayed Testing Group (Cohort B)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age: 50 years.
• 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
• 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
• Patients are able to attend study visits and standard care visits over the period of 1 year from the date of enrollment
• 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
• 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
• 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.

You may not qualify if:

• Patients younger than 50 years of age
• Patients being evaluated for cognitive impairment known to be predominantly the result of a disease or condition other than AD
• Patients previously diagnosed with AD, unless the ADELAIDE investigator has a strong clinical suspicion suggestive of an incorrect initial diagnosis upon referral
• Patients with no cognitive impairment or clinical symptoms of AD
• Patients desiring genetic testing for Alzheimer's disease markers without current cognitive impairment or other relevant clinical symptoms
• 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
• 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
• Patients who are not able to commit to attending the required study and/or standard care visits
• Patients who are not able to undergo routine phlebotomy or provide blood samples in the quantity required by the study protocol

Sponsors & Collaborators

• C2N Diagnostics: lead
• Alzheimer's Association: collaborator

Related Publications (3)

• Meyer MR, Kirmess KM, Eastwood S, Wente-Roth TL, Irvin F, Holubasch MS, Venkatesh V, Fogelman I, Monane M, Hanna L, Rabinovici GD, Siegel BA, Whitmer RA, Apgar C, Bateman RJ, Holtzman DM, Irizarry M, Verbel D, Sachdev P, Ito S, Contois J, Yarasheski KE, Braunstein JB, Verghese PB, West T. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Abeta42/40 ratio to identify presence of brain amyloid. Alzheimers Dement. 2024 May;20(5):3179-3192. doi: 10.1002/alz.13764. Epub 2024 Mar 16.

  PMID: 38491912 BACKGROUND

• Palmqvist S, Tideman P, Mattsson-Carlgren N, Schindler SE, Smith R, Ossenkoppele R, Calling S, West T, Monane M, Verghese PB, Braunstein JB, Blennow K, Janelidze S, Stomrud E, Salvado G, Hansson O. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care. JAMA. 2024 Oct 15;332(15):1245-1257. doi: 10.1001/jama.2024.13855.

  PMID: 39068545 BACKGROUND

• Schindler SE, Galasko D, Pereira AC, Rabinovici GD, Salloway S, Suarez-Calvet M, Khachaturian AS, Mielke MM, Udeh-Momoh C, Weiss J, Batrla R, Bozeat S, Dwyer JR, Holzapfel D, Jones DR, Murray JF, Partrick KA, Scholler E, Vradenburg G, Young D, Algeciras-Schimnich A, Aubrecht J, Braunstein JB, Hendrix J, Hu YH, Mattke S, Monane M, Reilly D, Somers E, Teunissen CE, Shobin E, Vanderstichele H, Weiner MW, Wilson D, Hansson O. Acceptable performance of blood biomarker tests of amyloid pathology - recommendations from the Global CEO Initiative on Alzheimer's Disease. Nat Rev Neurol. 2024 Jul;20(7):426-439. doi: 10.1038/s41582-024-00977-5. Epub 2024 Jun 12.

  PMID: 38866966 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Vice President, Neurology

  C2N Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment interventional model in which participants are randomized into one of two groups to evaluate the impact of the timing of PrecivityAD2 test on physician diagnostic confidence and clinical decision-making. Participants in the early testing group receive their PrecivityAD2 test at Visit 1, while those in the delayed testing group receive their results at Visit 3 (Day 90). Both groups proceed independently through the study, and assessments occur at standardized time points to measure changes in diagnostic confidence, treatment decision, and diagnostic test utilization.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12