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

NCT02309723 | Completed Results

• 1 other identifier: CEVR-2013-001
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Keywords

Alzheimer's Disease; Mild Cognitive Impairment; Neuroimaging; Diagnostic Tool

Outcome Measures

Primary Outcomes (3)

• 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.

  Online Survey - completion during the estimated 2-3 month field period

• 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).

  Online Survey - completion during the estimated 2-3 month field period

• 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.

  Online Survey - completion during the estimated 2-3 month field period

Study Arms (3)

Positive beta amyloid findings

EXPERIMENTAL

Beta amyloid imaging results indicated a positive finding.

Device: Beta amyloid imaging

Negative beta amyloid findings

EXPERIMENTAL

Beta amyloid imaging results indicated a negative finding.

Device: Beta amyloid imaging

No beta amyloid information

NO INTERVENTION

Interventions

Beta amyloid imaging DEVICE

Negative beta amyloid findings; Positive beta amyloid findings

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• GE Healthcare: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr.Yue Zhong, Project Director of Center for the Evaluation of Value and Risk in Health
• Organization: Tufts Medical Center

yzhong@tuftsmedicalcenter.org

6176361424

Study Officials

• Joshua T. Cohen, Ph.D

  Tufts Medical Center

  STUDY DIRECTOR

• Peter J Neumann, ScD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

US (1)