Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO

Status unconfirmed

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT02835716

Run by

Millennium Magnetic Technologies, LLC

People needed

150

Starts

2016-09-01

Expected to finish

2020-09-01

Last updated by the study team

2016-09-13

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50 to 75 years old,
• Normal baseline cognitive function by standard psychometric testing.
• Able to privately fund psychometric and neuroimaging studies if not covered by their insurance,
• Able to give written Informed Consent,
• Ascent for collaboration by their primary care or specialty physician,
• Currently taking (<1 month) or planning to take (within the next 3 months) medications which are identified in the study group of interest, prescribed by and under the care of a PMD or specialty physician.

You may not qualify if…

• Inability to undergo MR Imaging : Claustrophobia, certain metal implants,

Where it is running

• Millennium Magnetic Technologies, LLC — Westport, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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