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All Subjects for Mild Cognitive Impairment

Phase 2
Waitlist Available
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signed and dated written informed consent must be obtained from the subject to enter the study and before any assessment is performed.
Pregnancy: Participant is not pregnant at the time of the PET and MRI imaging exams. Urine pregnancy tests will be conducted as needed with pre-menopausal women who are of child-bearing potential.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

Study Summary

This study is evaluating whether a PET radioligand can help identify people with Alzheimer's disease.

Eligible Conditions
  • Mild Cognitive Impairment
  • Alzheimer's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake
Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Clinical Dementia Rating Scale (CDR).
Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Mini-Mental Status Exam (MMSE)
+1 more

Side effects data

From 2022 Phase 2 trial • 27 Patients • NCT03919669
8%
Infusion Site Extravasation
8%
Injection Site Reaction
8%
Back Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dementia
Mild Cognitive Impairment
Healthy Volunteer

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment1 Intervention
All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
All Subjects
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,979 Total Patients Enrolled
Cerveau Technologies, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025