Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Neuroimaging, Diagnostic Tool
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.
Interventions
DEVICEBeta amyloid imaging
Sponsors
GE Healthcare
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Beta Amyloid Findings Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding. | 106 |
| Negative Beta Amyloid Findings Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding. | 105 |
| No Beta Amyloid Information Survey respondents presented scenario with no beta amyloid information. | 104 |
| Total | 315 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 24 | 23 | 24 |
Baseline characteristics
| Characteristic | Positive Beta Amyloid Findings | Negative Beta Amyloid Findings | No Beta Amyloid Information | Total |
|---|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 8.8 | 51.5 years STANDARD_DEVIATION 7.8 | 52.7 years STANDARD_DEVIATION 8 | 51.8 years STANDARD_DEVIATION 8.2 |
| Beta Amyloid imaging findings | 106 participants | 105 participants | 104 participants | 315 participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 87 Participants | 134 Participants |
| Sex: Female, Male Male | 82 Participants | 82 Participants | 17 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 105 | 0 / 104 |
| serious Total, serious adverse events | 0 / 106 | 0 / 105 | 0 / 104 |
Outcome results
Primary
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.
Time frame: Online Survey - completion during the estimated 2-3 month field period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Positive Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: very confident | 25 participants |
| Positive Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: confident | 43 participants |
| Positive Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: not at all confident | 3 participants |
| Positive Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: somewhat confident | 31 participants |
| Positive Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: extremely confident | 3 participants |
| Negative Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: confident | 38 participants |
| Negative Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: not at all confident | 12 participants |
| Negative Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: somewhat confident | 34 participants |
| Negative Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: very confident | 18 participants |
| Negative Beta Amyloid Findings | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: extremely confident | 4 participants |
| No Beta Amyloid Information | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: extremely confident | 5 participants |
| No Beta Amyloid Information | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: very confident | 14 participants |
| No Beta Amyloid Information | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: not at all confident | 9 participants |
| No Beta Amyloid Information | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: confident | 46 participants |
| No Beta Amyloid Information | Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss | Diagnosis confidence: somewhat confident | 30 participants |
Primary
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).
Time frame: Online Survey - completion during the estimated 2-3 month field period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Beta Amyloid Findings | Likelihood of Recommending a Medication Indicated for Alzheimer's Disease | 93 participants |
| Negative Beta Amyloid Findings | Likelihood of Recommending a Medication Indicated for Alzheimer's Disease | 76 participants |
| No Beta Amyloid Information | Likelihood of Recommending a Medication Indicated for Alzheimer's Disease | 92 participants |
Primary
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.
Time frame: Online Survey - completion during the estimated 2-3 month field period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Beta Amyloid Findings | Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures | 67 participants |
| Negative Beta Amyloid Findings | Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures | 61 participants |
| No Beta Amyloid Information | Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures | 66 participants |