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

Part of paid clinical trials in Westport, Connecticut.

Sponsor
Millennium Magnetic Technologies, LLC
Study ID
NCT02835716
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • roflumilast — DRUG
    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
  • ustekinumab — BIOLOGICAL
    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

Study Details

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 Dates

Start date
Sep 30, 2016
Status verified
Sep 2016
Primary completion
Sep 30, 2019
Completion
Sep 30, 2020

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Number of Participants who Develop Cognitive Decline [ Time Frame: 18-24 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Millennium Magnetic Technologies, LLCWestportConnecticut06880
Steve Levy, MD
[email protected]
203-423-9494
Donald H Marks, MD PhD
[email protected]
9733070364

Find similar trials in Westport, CT

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Millennium Magnetic Technologies, LLC· Westport, CT

Related Studies