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

NCT02835716 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

roflumilast

DALIRESP is used in adults with severe chronic obstructive pulmonary disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations

BIOLOGICAL

ustekinumab

STELARA is approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body

Sponsors & Collaborators

  • Millennium Magnetic Technologies, LLC

    lead INDUSTRY

Principal Investigators

  • Donald H Marks, MD PhD · MMT

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835716 on ClinicalTrials.gov