Screening Visit
Signing of Informed Consent Form
A member of the research staff will present and review in detail the items in the informed consent form with the individual or their Legally Authorized Representative (Healthcare Surrogate) and answer any questions they may have. To proceed in the study, the individual or their Legally Authorized Representative (Healthcare Surrogate) must willingly sign the informed consent form at this time. No study procesures will commence until a signed informed consent form is obtained by the research staff.
Assignment of Subject Identification Number
The subject will be assigned a unique subject identification number based upon his or her order of entry into the study. All data collected will be labeled with this unique subject identification number. No identifiers will be included that could link the information back to the study participant.
Additional information about the informed consent and subject ID number assignment is contained in a later section of the protocol titled, “SAFETY AND CONFIDENTIALITY ISSUES.”
Measurements and Evaluations
Pre-procedure measurements and evaluations will occur over one day. The pre-procedure measurements and assessments will be conducted by the Principal Investigator, psychometrician and/or cognitive rater.
The following variables will be recorded for each subject at the Screening Visit:
Demographic Variables
- Gender: Male or female
- Age
- Ethnicity: Caucasian, Hispanic, African American, American Indian, Asian/Pacific Islander, Other
Alzheimer’s History and Symptoms
- Age of onset and duration of disease state
- List of current medications for the management of the subject’s disease
- List of co-morbid conditions
Other Variables
- All medications taken in the past 12 months for a period of two weeks or longer: include details of dosage, duration of use, what the medication was used for, etc., as applicable
- All therapies engaged in the past 12 months for any indication other than Alzheimer’s including all conventional and alternative therapies.
Medical Measurements
- Height
- Weight
- Blood pressure
Cognitive Assessments and Subject/Study Partner Interviews
- Alzheimer’s Disease Assessment Scale-Cog (ADAS-cog)
- Neuropsychiatric Inventory Questionnaire (NPI)
- Clinical Dementia Rating Scale (CDR)
- Mini-Mental state examination (MMSE)
- Modified Activities of Daily Living (ADL) Inventory
Subject Group Randomization
After all the screening procedures are completed, the subject will be randomly assigned to treatment group A, B, or C following the methodology outlined above in the STUDY DESIGN section of the protocol.
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