This Observational protocol will attempt to verify two recent and very critical concepts in
ALZ Clinical Research by studying high-risk individuals who already are taking medications
which may prevent the onset of ALZ.
- It may be possible to determine the future development of ALZ in a preclinical state in
a cognitively normal but high risk individual at least 18-24 months before any symptoms
develop of cognitive impairment.
- Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ
can prevent of delay the occurrence and severity of ALZ.
Caveats
Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat ALZ,
nor develop or use medications or diagnostic neuroimaging outside of already approved and
accepted parameters. Persons who volunteer to be study subjects in this observational
protocol will be under the care of their primary care / specialty physician, who will order
tests and treatments as they see appropriate.
Although there is a very large body of peer-reviewed scientific literature demonstrating that
certain functional MRI patterns are associated with certain neurologic conditions, the
utilization of fMRI for the evaluation of neurologic disorders is still considered an
emerging science and therefore in the investigational stage. Although this protocol will
report on brain patterns of certain neurologic conditions such as cognitive impairment and
Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are
not considered stand alone or diagnostic per se and should always be considered by the PMD in
conjunction with the patient's clinical condition. These data should only be used as
additional information to add to the PMD's diagnostic impression.