Assessment of Treatment Response in Alzheimer[Single Quote]s Disease with Imaging Markers

Study ID
STU 072013-037

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Zohre German
214-505-5650
zohre.german@utsouthwestern.edu

Principal Investigator
Hanzhang Lu

Summary

The study will be conducted with an open label design.That is, patients who are prescribed aricept[RegisteredTM] as part of their standard of care will be eligible to participate in this study. The initiation of aricept[RegisteredTM] and any subsequent increase in dosage from 5 to 10 mg/day is part of the patient's standard of care and not associated with study performance. Pi will either notify the coordinator that a patient has been prescribed aricept[RegisteredTM] and/or the coordinator will review for eligible study subjects thru the clinic schedule. (no data will be collected from epic. after consent and prior to study medication, we will perform an MRi and measure their cognitive function using the (Hopkins Verbal Learning Test HVLT); Texas assessment of Processing Speed (TaPS); Montreal Cognitive assessment (MoCa); Mini Mental State examination (MMSe) D-KeFS Verbal Fluency. These cognitive tests combined should take approximately 30 x 40 minutes in total. The subjects will then start aricept[RegisteredTM] at 5mg/day for one month, and if they can tolerate it, the dose will be increased to 10mg/day afterwards. at two month post-medication, they will be scanned and cognitively evaluated again. The MRi session is expected to take less than 60 minutes. The MoCa; HVLT; TaPS; MMSe D-KeFS Verbal Fluency combined will take approximately 30 x 40 minutes in total.
Revised Protocol: added: Trails a and B and Digit Symbol. This increased the time 60 minutes in total.

Participant Eligibility

Inclusion:
Cognitively impaired subjects 50 - 90 years of age will be included as this is inherent to the study population suffering from Mild Cognitive Impairment (MCI) and Alzheimer[Single Quote]s disease. To be included in the study, subjects will have a MMSE score of >= 15 at their most recent core Alzheimer[Single Quote]s Disease Center (ADC) visit, within the past year. The research staff will carefully evaluate patient and Legally Authorized Representative (LAR) understanding. The researchers will spend additional time explaining the consent form to this group of potential subjects.
Inclusion
Subjects age 50 x 90.
Primary diagnosis of MCI or AD (from the early MCI, AD cohort of the UT Southwestern ADC) and/or the Memory Research/Disorders Clinic in Department of Neurology at Aston.
MMSE score of >= 15 (at their most recent visit.)
Must be capable and willing to undergo Magnetic Resonance Imaging (MRI)
Blood Pressure < 160/90
Naive to acetylcholinesterase inhibitors; prescribed Aricept by a physician.