NCT06025877: QUIP II

Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey

Status unknown Last updated 28 March 2025

What this trial tests

trial testing PrecivityAD2(TM) blood test in Alzheimer Disease in 400 participants. Status unknown.

Timeline

15 November 2023

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	C2N Diagnostics
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	15 November 2023
Primary completion	30 April 2025
Estimated completion	30 April 2025
Sites	9 locations across United States

Drugs / interventions tested

• PrecivityAD2(TM) blood test

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Dementia — all drugs for Dementia →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

C2N Diagnostics — full company profile →

Who can join

55 and older, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Utility of an Alzheimer's Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study.
   Monane M, Maraganore DM, Carlile RM, Johnson KG, et al · · 2025 · cited 6× · PMID 39857051 · DOI 10.3390/diagnostics15020167
2. The Effect of Patient Age and Sex on Decision-Making Around An Alzheimer’s Disease Blood Test: QUIP II Study Results
   · 2025
3. Full GSA 2025 Abstract Book PDF
   · 2025
4. Implementation of an Alzheimer's Disease Blood Test: Adoption Experience by Memory Care Specialists in a Multi-Center Study.
   Monane M, Carlile RM, Johnson KG, Gitelman DR, et al · · 2025 · PMID 41149831 · DOI 10.3390/jpm15100469
5. SUPPORTING AGING THROUGH HOUSING CHOICE: A DISCUSSION TOOL FOR COLLABORATION TOWARD LOCAL SOLUTIONS
   · 2024
6. IMPLEMENTATION STUDY OF THE USE OF A BLOOD BIOMARKER TEST IN ALZHEIMER’S DISEASE: CLINICIAN SURVEY FROM QUIP II STUDY
   · 2024
7. IMPROVING CARE THROUGH IMPROV: RESULTS OF A PILOT TEST WITH FAMILY AND FRIENDS OF PERSONS LIVING WITH DEMENTIA
   · 2024
8. COGNITIVE DECLINE AMONG OLDER ADULTS FOLLOWING TRAUMATIC BRAIN INJURY
   · 2024