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Alzheimer DiseaseQUIP IINCT06025877

Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by C2N Diagnostics at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
PrecivityAD2(TM) blood test
How many people
400 participants
Where
9 sitesUnited States
Study dates
15 Nov 2023to 30 Apr 2025
Phase
Observational
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 55 years and older
  • All sexes
  • Adult, Older adult

Study population: The study population will include up to 40 memory care specialists who will use the PrecivityAD2 blood test and complete the respective surveys. Participating clinicians will be selected based on their ability to meet the acceptance measures from the inclusion and exclusion criteria. Cohort A will include up to 100 test samples collected for the PrecivityAD2 blood test. Cohort B will include up to 300 test samples collected for the PrecivityAD2 blood test.

Physician Inclusion Criteria:

  1. Memory care specialists actively practicing in the United States
  2. Practice serves individuals with MCI or dementia age > 55 years
  3. Average patient volume > 25 visits per week (all patients seen across practice)
  4. Memory care specialist with access to an online electronic survey

Physician Exclusion Criteria:

  1. Clinicians who practice in New York

Participant Inclusion Criteria:

  1. Individual with MCI or dementia
  2. Age >= 55 years

Participant Exclusion Criteria

  1. Individual requiring test related blood draw within the state of New York
  2. Participation does not seem to be in the best interest of the individual, per the ordering clinician

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Josephson Wallack Munshower Neurology, P.C.

    Indianapolis, Indiana, 46256

  • Tulane Doctors Neurosurgery Clinic

    New Orleans, Louisiana, 70006

  • Memorial Healthcare Institute for Neuroscience

    Owosso, Michigan, 48867

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721

  • Advocate Memory Center

    Park Ridge, Illinois, 60068

  • UCSF Memory and Aging Center

    San Francisco, California, 94158

  • Pacific Brain Health Center

    Santa Monica, California, 90404

  • C2N Diagnostics

    St Louis, Missouri, 63110

  • Palmetto Primary Care Physicians

    Summerville, South Carolina, 29486

Other trials in United States

About this study

Official title: Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022).

Read the detailed description

The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP II) represents a large-scale initiative for the PrecivityAD2 blood test for use by neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients aged 55 years and older with signs or symptoms of MCI or dementia.

C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.

Being tested
PrecivityAD2(TM) blood test
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia, Memory Disorders

What participants receive

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

  • PrecivityAD2(TM) blood testOther

    Also called AD2

    The PrecivityAD2 blood test measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.

Study groups in NCT06025877
Study groupRoleWhat they receive
Cohort AOne time clinician survey post-test following the receipt of the PrecivityAD2 blood test result
Receives: Other: PrecivityAD2(TM) blood test
Cohort BPre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result
Receives: Other: PrecivityAD2(TM) blood test

What is being measured

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

  1. Change in planned clinical management (Cohort A and B)

    The association of the test result on medical decision making

    Measured: Day 20

  2. Change in planned clinical management (Cohort B)

    Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result

    Measured: Day 0 vs Day 20

  3. Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)

    Evaluate the intended use criteria

    Measured: Day 90

Secondary outcomes (7)

  1. Relationship between the test result and actual clinical management (Cohort B)

    Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting

    Measured: Day 90

  2. Change in planned clinical management compared to conducted clinical management (Cohort B only)

    The evaluation of planned versus conducted change in management as a result of receiving the test result

    Measured: Day 20 vs Day 90

  3. Change in probability of AD (Cohort A and B)

    Evaluate the probability of an AD Dx pre and post receipt of the test result

    Measured: Day 0 vs Day 20

  4. Change in anti-AD medication use (Cohort A and B)

    Evaluate anti-AD medication use pre- and post-receipt of the test result

    Measured: Day 0 vs Day 20

  5. Change in diagnosis (Cohort B)

    Evaluate any changes in diagnoses as a result of receiving the AD test result

    Measured: Day 0 vs Day 90

  6. Relationship between the test result and planned testing (Cohort B)

    Evaluate the association between subsequent test ordering pre and post testing

    Measured: Day 0 vs Day 20 vs Day 90

  7. Correlations between the net promoter score and ease of use by APS2 result (Cohort B)

    Focus group questions around net promoter score and ease of use, strengths, and limitations of testing

    Measured: Day 90

Timeline

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

  1. First posted6 Sep 2023
  2. Study start15 Nov 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06025877
Sponsor's protocol ID
C2N002
Acronym
QUIP II
Status last verified
Mar 2024
First submitted
30 Aug 2023
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Monane M, Maraganore DM, Carlile RM, Johnson KG, Merrill DA, Gitelman DR, Sharlin KS, VandeVrede LA, George KK, Wang J, West T, Jacobs L, Verghese PB, Braunstein JB. Clinical Utility of an Alzheimer's Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study. Diagnostics (Basel). 2025 Jan 13;15(2):167. doi: 10.3390/diagnostics15020167.

    PubMed 39857051

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by C2N Diagnostics at 9 sites in United States.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Change in planned clinical management (Cohort A and B) (time frame: Day 20). The study lists 3 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 NCT06025877, which also lists 1 linked publication.

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 28 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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