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Alzheimers DiseaseADELAIDENCT06856681

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

A study testing PrecivityAD2 - Early Testing and PrecivityAD2 - Delayed Testing in people with Alzheimers Disease, run by C2N Diagnostics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimers Disease
What is being tested?
PrecivityAD2 - Early Testing and PrecivityAD2 - Delayed Testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2025to Mar 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States

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.

Read the detailed description

Healthcare providers engaged in memory care and Alzheimer's disease (AD) management have shown significant interest in the performance of plasma tests. A collaboration with Veteran's Affairs (VA) and other closed healthcare systems represents an opportunity to examine the clinical validity and utility of blood biomarkers (BBM). The ADELAIDE study is a prospective, randomized, clinical utility, economic impact and real-world study. The BBM test under study is the PrecivityAD2 blood test that uses high-resolution liquid chromatography mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217 ratios. This study will assess and quantify the impact of BBM testing to overall time-to-diagnosis and time to prescription of an appropriate Alzheimer's Disease (AD) or non-AD therapy. Additionally, this study will assess the impact of BBM testing to procedure utilization and overall costs of healthcare and will assess the diagnostic confidence of clinicians that order the test.

Being tested
PrecivityAD2 - Early Testing, PrecivityAD2 - Delayed Testing
Keywords
Blood biomarkers, Mild Cognitive Impairment, Dementia, Alzheimers disease
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrecivityAD2 - Early TestingDiagnostic test

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

  • PrecivityAD2 - Delayed TestingDiagnostic test

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

Study groups in NCT06856681
Study groupRoleWhat they receive
Early Testing Group (Cohort A)ExperimentalParticipants 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.
Receives: Diagnostic Test: PrecivityAD2 - Early Testing
Delayed Testing Group (Cohort B)ExperimentalParticipants 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.
Receives: Diagnostic Test: PrecivityAD2 - Delayed Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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%.

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

Secondary outcomes (4)

  1. Time to Initiation or Modification of AD or Non-AD Therapy

    Number of days from enrollment to the prescription, initiation, or modification of an AD or non-AD therapy. Data will be sourced from medical records and recorded in eCRF.

    Measured: Measured from enrollment through Visit 4 (Day 365).

  2. Proportion of patients on AD or non-AD prescription

    Proportion of patients on AD or non-AD prescription (e.g., DMT, treatments for DLB/PDD or VaD, cholinesterase inhibitors, other) at Visit 3 (150-210).

    Measured: Assessed at Visit 3 (150-210)

  3. Number and Type of Diagnostic Tests Ordered

    Total number and type of additional diagnostic tests ordered (e.g., amyloid PET, MRI, CSF biomarkers) from Visit 2 (Day 90) through the date of AD or non-AD diagnosis with physician confidence >=90%. Data will be collected via physician-reported case forms.

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

  4. Change in Physician Diagnostic Confidence

    Comparison of physician reported confidence of AD or non-AD diagnosis (0-100%) before and after receiving PrecivityAD2 results. Confidence scores will be collected by physician survey.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Why it stopped: sponsor decision to cancel project before enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06856681
Sponsor's protocol ID
250
Acronym
ADELAIDE
Status last verified
Dec 2025
First submitted
6 Feb 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38491912

  • 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.

    PubMed 39068545

  • 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.

    PubMed 38866966

Questions about this trial

What is this clinical trial studying?

A study testing PrecivityAD2 - Early Testing and PrecivityAD2 - Delayed Testing in people with Alzheimers Disease, run by C2N Diagnostics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to achieve >=90% Diagnostic Confidence for AD or Non-AD (time frame: From enrollment until diagnosis, with primary assessment at Visit 2 (Day 90) and Visit 3 (Day 180).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06856681, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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