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

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02309723
• Collaborator: GE Healthcare (Industry)
• Enrollment: 315
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 157.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease; Mild Cognitive Impairment	Device: Beta amyloid imaging	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

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

Outcome Measures

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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center
• GE Healthcare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT02309723
• Other Study ID Numbers: CEVR-2013-001
• First Posted: Dec 5, 2014
• Last Update Posted: Apr 10, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Tufts Medical Center: Alzheimer's Disease; Mild Cognitive Impairment; Neuroimaging; Diagnostic Tool
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Positive Beta Amyloid Findings	Negative Beta Amyloid Findings	No Beta Amyloid Information
Arm/Group Description	Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging
Period Title: Overall Study
STARTED	129	128	129
COMPLETED	105	105	105
NOT COMPLETED	24	23	24

Baseline Characteristics

Arm/Group Title	Positive Beta Amyloid Findings	Negative Beta Amyloid Findings	No Beta Amyloid Information	Total
Arm/Group Description	Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.	Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.	Survey respondents presented scenario with no beta amyloid information.	Total of all reporting groups
Overall Participants	106	105	104	315
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.3 (8.8)	51.5 (7.8)	52.7 (8.0)	51.8 (8.2)
Sex: Female, Male (Count of Participants)
Female	24 22.6%	23 21.9%	87 83.7%	134 42.5%
Male	82 77.4%	82 78.1%	17 16.3%	181 57.5%
Beta Amyloid imaging findings (participants) [Number]
Number [participants]	106 100%	105 100%	104 100%	315 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Beta Amyloid Findings	Negative Beta Amyloid Findings	No Beta Amyloid Information
Arm/Group Description	Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging
Measure Participants	105	106	104
Diagnosis confidence: not at all confident	3 2.8%	12 11.4%	9 8.7%
Diagnosis confidence: somewhat confident	31 29.2%	34 32.4%	30 28.8%
Diagnosis confidence: confident	43 40.6%	38 36.2%	46 44.2%
Diagnosis confidence: very confident	25 23.6%	18 17.1%	14 13.5%
Diagnosis confidence: extremely confident	3 2.8%	4 3.8%	5 4.8%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Beta Amyloid Findings	Negative Beta Amyloid Findings	No Beta Amyloid Information
Arm/Group Description	Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging
Measure Participants	106	105	104
Number [participants]	93 87.7%	76 72.4%	92 88.5%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Positive Beta Amyloid Findings	Negative Beta Amyloid Findings	No Beta Amyloid Information
Arm/Group Description	Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging
Measure Participants	106	105	104
Number [participants]	67 63.2%	61 58.1%	66 63.5%

Adverse Events

Arm/Group Title	Positive Beta Amyloid Findings		Negative Beta Amyloid Findings		No Beta Amyloid Information
Arm/Group Description	Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging		Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging
All Cause Mortality
	Positive Beta Amyloid Findings		Negative Beta Amyloid Findings		No Beta Amyloid Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Positive Beta Amyloid Findings		Negative Beta Amyloid Findings		No Beta Amyloid Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/105 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Positive Beta Amyloid Findings		Negative Beta Amyloid Findings		No Beta Amyloid Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/105 (0%)		0/104 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.