ERK AD-Index in the Diagnosis of Alzheimer[Single Quote]s Disease: Clinical Feasibility Protocol

Study ID
STU 102010-016

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kathleen Koch
214-648-9343
kathleen.koch@utsouthwestern.edu

Principal Investigator
Mary Quiceno

Summary

There are no treatment arms, placebo comparison or randomizations in this trial. Subjects will come in for a one time visit for a punch biopsy, blood work, physical exam and/or medical history. at that time subjects will be told that some time in the future, when they die, the researchers may ask their next of kin for permission to perform an autopsy of their brain and spinal column. at this same visit subjects will be informed that if they do not wish to give permission for a brain and spinal cord autopsy, please tell the researchers now.

The feasibility study is to establish the proportion agreement between the eRK aD index and postmortem pathology report, and to determine whether to conduct a confirmatory clinical trial and to establish thresholds for best overall agreement between the various research biomarkers being evaluated and the postmortem pathology report.

Participant Eligibility

Remaining active subjects will be asked to participate in this blood collection addendum of the study.

1.Subject presenting at the memory clinic who are who have been diagnosed clinically with dementia who have one or more of the following criteria: Mini-Mental State Examination (MMSE) score of 24 or less or an Revised Hasegawa's dementia scale (HDS-R) score of 20 or less or a Clinical Dementia Rating (CDR) of 1 or more.
2.Subject, caregiver, authorized representative, or legal guardian provides informed consent to participate in study.
3.Subject, caregiver, authorized representative, or legal guardian provides assent for patient to have a brain autopsy at death, with results contributing to the study.
4.Subject is least 50 years old.
5.Subject attained an 8th grade education or had a significant work history.
6.Subject agrees to a skin punch biopsy of approximately 2-3.5 mm in diameter.
7.Subject, caregiver, authorized representative, or legal guardian agrees to a skin punch biopsy of approximately 2.5-3.5 mm in diameter and a phlebotomy of approximately 10 mL (2 teaspoons) of blood at the time of enrollment.