Trial Outcomes & Findings for Influence of Beta Amyloid Imaging on Care of Patients Cognitive Complaints. (NCT NCT02309723)

Results Overview

Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

315 participants

Primary outcome timeframe

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

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Positive Beta Amyloid Findings Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Negative Beta Amyloid Findings Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging	No Beta Amyloid Information
Overall Study STARTED	129	128	129
Overall Study COMPLETED	105	105	105
Overall Study NOT COMPLETED	24	23	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Positive Beta Amyloid Findings Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Negative Beta Amyloid Findings Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging	No Beta Amyloid Information
Overall Study Withdrawal by Subject	24	23	24

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Beta Amyloid Findings n=106 Participants Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.	Negative Beta Amyloid Findings n=105 Participants Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.	No Beta Amyloid Information n=104 Participants Survey respondents presented scenario with no beta amyloid information.	Total n=315 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 8.8 • n=99 Participants	51.5 years STANDARD_DEVIATION 7.8 • n=107 Participants	52.7 years STANDARD_DEVIATION 8.0 • n=206 Participants	51.8 years STANDARD_DEVIATION 8.2 • n=7 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	23 Participants n=107 Participants	87 Participants n=206 Participants	134 Participants n=7 Participants
Sex: Female, Male Male	82 Participants n=99 Participants	82 Participants n=107 Participants	17 Participants n=206 Participants	181 Participants n=7 Participants
Beta Amyloid imaging findings	106 participants n=99 Participants	105 participants n=107 Participants	104 participants n=206 Participants	315 participants n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positive Beta Amyloid Findings n=105 Participants Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Negative Beta Amyloid Findings n=106 Participants Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging	No Beta Amyloid Information n=104 Participants
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	12 participants	9 participants
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	38 participants	46 participants
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	18 participants	14 participants
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	4 participants	5 participants
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	34 participants	30 participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Positive Beta Amyloid Findings n=106 Participants Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Negative Beta Amyloid Findings n=105 Participants Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging	No Beta Amyloid Information n=104 Participants
Likelihood of Recommending a Medication Indicated for Alzheimer's Disease	93 participants	76 participants	92 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Positive Beta Amyloid Findings n=106 Participants Beta amyloid imaging results indicated a positive finding. Beta amyloid imaging	Negative Beta Amyloid Findings n=105 Participants Beta amyloid imaging results indicated a negative finding. Beta amyloid imaging	No Beta Amyloid Information n=104 Participants
Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures	67 participants	61 participants	66 participants

Adverse Events

Positive Beta Amyloid Findings

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Beta Amyloid Findings

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Beta Amyloid Information

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Yue Zhong, Project Director of Center for the Evaluation of Value and Risk in Health

Tufts Medical Center

Phone: 6176361424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place