Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey

NCT06025877 | Active Not Recruiting

• 1 other identifier: C2N002
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 9

Brief 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. 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).

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia; Cognitive Decline; Cognitive Impairment; Memory Impairment

Outcome Measures

Primary Outcomes (3)

• Change in planned clinical management (Cohort A and B)

  The association of the test result on medical decision making

  Day 20

• 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

  Day 0 vs Day 20

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

  Evaluate the intended use criteria

  Day 90

Secondary Outcomes (7)

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

  Day 90

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

  Day 20 vs Day 90

• Change in probability of AD (Cohort A and B)

  Day 0 vs Day 20

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

  Day 0 vs Day 20

• Change in diagnosis (Cohort B)

  Day 0 vs Day 90

Study Arms (2)

Cohort A

One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result

Other: PrecivityAD2(TM) blood test

Cohort B

Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result

Other: PrecivityAD2(TM) blood test

Interventions

PrecivityAD2(TM) blood test OTHER

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.

Also known as: AD2

Cohort A; Cohort B

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• \) Clinicians who practice in New York
• Individual with MCI or dementia
• Age \>= 55 years
• Individual requiring test related blood draw within the state of New York
• Participation does not seem to be in the best interest of the individual, per the ordering clinician

Sponsors & Collaborators

• C2N Diagnostics: lead

Study Sites (9)

UCSF Memory and Aging Center

San Francisco, California, 94158, United States

Location

Pacific Brain Health Center

Santa Monica, California, 90404, United States

Location

Advocate Memory Center

Park Ridge, Illinois, 60068, United States

Location

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

Location

Tulane Doctors Neurosurgery Clinic

New Orleans, Louisiana, 70006, United States

Location

Memorial Healthcare Institute for Neuroscience

Owosso, Michigan, 48867, United States

Location

Sharlin Health and Neurology

Ozark, Missouri, 65721, United States

Location

C2N Diagnostics

St Louis, Missouri, 63110, United States

Location

Palmetto Primary Care Physicians

Summerville, South Carolina, 29486, United States

Location

Related Publications (1)

• 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.

  PMID: 39857051 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Memory Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mark Monane, MD, MBA, AGSF

  C₂N Diagnostics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: November 15, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)