Influence of Beta Amyloid Imaging on Care of Patients Cognitive Complaints.

February 22, 2017 updated by: Tufts Medical Center

A Survey of Clinicians to Assess the Influence of Beta-amyloid Imagining Information on the Diagnosis and Management of Hypothetical Patients With Cognitive Complaints

When older patients develop cognitive problems - like memory loss - there may be any of several underlying causes, sometimes occurring in combination. Clinicians have a better chance of providing appropriate treatment if they understand what the cause of the problem is. A diagnostic tool can help the patient by helping the clinician to make a more accurate diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging - may potentially improve medical practice. The tool can potentially improve practice only if it can influence clinical judgment. This study investigates whether the provision of beta amyloid imaging information influences clinical judgment. The investigators will conduct a survey that presents clinicians with descriptions of hypothetical older patients with cognitive complaints. Some of the respondents also receive beta amyloid imaging information. The investigators will test the investigators hypothesis that the information will affect diagnostic judgment and management recommendations by comparing the responses of clinicians who receive the beta amyloid information to the responses of clinicians who do not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Practicing clinicians describing their training and practice as any of the following: neurologist, geriatrician, psychiatrist.
  • Included respondents must also attest that they are a physician who is experienced in the assessment and diagnosis of dementia.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive beta amyloid findings
Beta amyloid imaging results indicated a positive finding.
Device: Beta amyloid imaging
Experimental: Negative beta amyloid findings
Beta amyloid imaging results indicated a negative finding.
Device: Beta amyloid imaging
No Intervention: No beta amyloid information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss
Time Frame: Online Survey - completion during the estimated 2-3 month field period
Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.
Online Survey - completion during the estimated 2-3 month field period
Likelihood of Recommending a Medication Indicated for Alzheimer's Disease
Time Frame: Online Survey - completion during the estimated 2-3 month field period
Proportion of respondents who recommend a medication indicated for the treatment of Alzheimer's Disease, including Acetylcholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists, Typical antipsychotics - e.g., Chlorpromazine (Thorazine), Haloperidol (Haldol), Atypical antipsychotics - e.g., Clozapine (Clozaril), Risperidone (Risperdal), Antidepressant - e.g., Citalopram (Celexa), Venlafaxine (Effexor), Antianxiety agent - e.g. Benzodiazepines, Buspirone (Buspar).
Online Survey - completion during the estimated 2-3 month field period
Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures
Time Frame: Online Survey - completion during the estimated 2-3 month field period
Proportion of respondents who recommend that the patient's spouse take actions that would be appropriate if the patient has Alzheimer's disease, including: (1) discussion of advance care planning, (2) monitoring of patient's finances, (3) assessment of how compatible the patient's job is with his conditions, (4) the initiation of precautions to ensure the patient is properly taking his medications to manage hypertension and hyperlipidemia.
Online Survey - completion during the estimated 2-3 month field period

Collaborators and Investigators

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

Sponsor

Tufts Medical Center

Collaborators

GE Healthcare

Investigators

  • Study Director: Joshua T. Cohen, Ph.D, Tufts Medical Center
  • Principal Investigator: Peter J Neumann, ScD, Tufts Medical Center

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, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEVR-2013-001

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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