Alzheimer Disease Clinical Trial
Official title:
Pre-Clinical Alzheimer's (ALZ) Diagnosis (PCD) = Optimum Outcomes (OO)
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.
Prospective observational study participants age 50-75 years are identified who are
currently (<1 month) taking or will soon (within 3 months) start taking study medications of
interest thru their own physician.
Prospective observational study participants are explained how persons can be cognitively
normal but at high risk for developing clinical ALZ, and that this risk can be prospectively
identified.
They are advised that there is some rationale that medications they are or will soon be
taking may have a protective effect in delaying the onset of ALZ, and that protective effect
can be monitored.
They are asked if they would like to participate in a protocol that monitors their
prospective risk for developing ALZ short term, and whether certain of their prescribed
medications may have a protective effect. Those who are accepting to be participants are
then enrolled in the study.
Enrollees are tested for risk factors for having pre-clinical ALZ. Individuals identified as
being at risk at baseline are followed at 6 month intervals for a 24 month period using
psychometric testing and functional neuroimaging. Their maintenance of cognitive stability
or cognitive decline is monitored while under the care of their PMD and while taking
medications of interest.
;
Observational Model: Case-Only, Time Perspective: Prospective
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