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

September 10, 2016 updated by: Millennium Magnetic Technologies, LLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • Recruiting
        • Millennium Magnetic Technologies, LLC
        • Contact:
          • Donald H Marks, MD PhD
          • Phone Number: 9733070364
          • Email: DHM@MilMag.net
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults at high risk of developing ALZ within 18-48 months but are currently cognitively normal for their age sex matching group. Risk factors include parents with a history of ALZ, and/or positive APOE4 alleles.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Develop Cognitive Decline
Time Frame: 18-24 month
Cognitive decline is defined as a reduction from baseline performance within each individual of at least one standard deviation (SD) on at least one of the three principal outcome indices (DRS-2, RAVLT Sum of Trials 1-5 [T1- 5], RAVLT Delayed Recall [DR]).
18-24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Magnetic Technologies, LLC

Investigators

  • Principal Investigator: Donald H Marks, MD PhD, MMT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

July 10, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 10, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCD=OO ALZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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