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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309723
Recruitment Status : Completed
First Posted : December 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Device: Beta amyloid imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013


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



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309723


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
GE Healthcare
Investigators
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Study Director: Joshua T. Cohen, Ph.D Tufts Medical Center
Principal Investigator: Peter J Neumann, ScD Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02309723    
Other Study ID Numbers: CEVR-2013-001
First Posted: December 5, 2014    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Keywords provided by Tufts Medical Center:
Alzheimer's Disease
Mild Cognitive Impairment
Neuroimaging
Diagnostic Tool
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders