How Beta-amyloid Imagining Influences Clinician Diagnosis and Management of Hypothetical Patients With Cognitive Complaints

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309723
• Other study ID #: CEVR-2013-001
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: June 7, 2016
• Start date: September 2013

Study information

• Verified date: June 2016
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• Beta amyloid imaging

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of the neuroimaging test on a finding of AD as the underlying cause of the mild memory loss	Proportion of respondents who identify AD 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	No
Primary	Likelihood of recommending pharmaceutical treatment for AD	Proportion of respondents who recommend a medication indicated for the treatment of AD, including Acetylcholinesterase inhibitors, NMDA 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	No
Primary	Likelihood of recommending caretaker management for AD symptoms	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	No