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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beta amyloid imaging
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Mild Cognitive Impairment, Neuroimaging, Diagnostic Tool

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Positive beta amyloid findings

Negative beta amyloid findings

No beta amyloid information

Arm Description

Beta amyloid imaging results indicated a positive finding.

Beta amyloid imaging results indicated a negative finding.

Outcomes

Primary Outcome Measures

Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss
Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.
Likelihood of Recommending a Medication Indicated for Alzheimer's Disease
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).
Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
February 22, 2017
Sponsor
Tufts Medical Center
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02309723
Brief Title
Influence of Beta Amyloid Imaging on Care of Patients Cognitive Complaints.
Official Title
A Survey of Clinicians to Assess the Influence of Beta-amyloid Imagining Information on the Diagnosis and Management of Hypothetical Patients With Cognitive Complaints
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
GE Healthcare

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Neuroimaging, Diagnostic Tool

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive beta amyloid findings
Arm Type
Experimental
Arm Description
Beta amyloid imaging results indicated a positive finding.
Arm Title
Negative beta amyloid findings
Arm Type
Experimental
Arm Description
Beta amyloid imaging results indicated a negative finding.
Arm Title
No beta amyloid information
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Beta amyloid imaging
Primary Outcome Measure Information:
Title
Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss
Description
Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.
Time Frame
Online Survey - completion during the estimated 2-3 month field period
Title
Likelihood of Recommending a Medication Indicated for Alzheimer's Disease
Description
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).
Time Frame
Online Survey - completion during the estimated 2-3 month field period
Title
Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures
Description
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.
Time Frame
Online Survey - completion during the estimated 2-3 month field period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua T. Cohen, Ph.D
Organizational Affiliation
Tufts Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter J Neumann, ScD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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

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