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Cohort B for Mild Cognitive Impairment (QUIP II Trial)

N/A
Recruiting
Led By Mark Monane, MD, MBA, AGSF
Research Sponsored by C2N Diagnostics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 20 vs day 90
Awards & highlights
No Placebo-Only Group

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).

Eligible Conditions
  • Mild Cognitive Impairment
  • Cognitive Impairment
  • Dementia
  • Alzheimer's Disease
  • Memory Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 20 vs day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 20 vs day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in planned clinical management (Cohort A and B)
Change in planned clinical management (Cohort B)
Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)
Secondary study objectives
Change in anti-AD medication use (Cohort A and B)
Change in diagnosis (Cohort B)
Change in planned clinical management compared to conducted clinical management (Cohort B only)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result
Group II: Cohort AExperimental Treatment1 Intervention
One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result

Find a Location

Who is running the clinical trial?

C2N DiagnosticsLead Sponsor
2 Previous Clinical Trials
398 Total Patients Enrolled
Mark Monane, MD, MBA, AGSFPrincipal InvestigatorC₂N Diagnostics, LLC
~31 spots leftby Dec 2024