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Trial record 30 of 31 for:    alzheimer dijon

Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline

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ClinicalTrials.gov Identifier: NCT01703702
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : August 17, 2016
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir (18F)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
641 patients enrolled in the study. 21 patients withdrew before receiving a florbetapir (F18) PET scan. 620 patients received florbetapir and comprise the Safety Population; 2 patients did not have a valid PET scan. Therefore; 618 patients were randomized to the intervention or control arms and comprise the Efficacy Population.

Reporting Groups
  Description
Intervention

Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Control

Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration


Participant Flow:   Overall Study
    Intervention   Control
STARTED   308   310 
COMPLETED   272   288 
NOT COMPLETED   36   22 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention

Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Control

Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 308   310   618 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.1  (8.2)   72.7  (7.94)   72.9  (8.07) 
Gender 
[Units: Participants]
     
Female   142   160   302 
Male   166   150   316 
Region of Enrollment 
[Units: Participants]
     
United States   112   111   223 
Italy   109   112   221 
France   87   87   174 


  Outcome Measures

1.  Primary:   Clinical and Diagnostic Change in Patient Management   [ Time Frame: Baseline and 3 months ]

Measure Type Primary
Measure Title Clinical and Diagnostic Change in Patient Management
Measure Description Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Control Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

Measured Values
   Intervention   Control 
Participants Analyzed   300   299 
Clinical and Diagnostic Change in Patient Management 
[Units: Percentage of patients]
 68.0   55.5 


Statistical Analysis 1 for Clinical and Diagnostic Change in Patient Management
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.002
Odds Ratio (OR) [5] 1.70
95% Confidence Interval 1.22 to 2.38
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   Change in ADAS-Cog 11 Total Score   [ Time Frame: Baseline and 12 months ]

Measure Type Primary
Measure Title Change in ADAS-Cog 11 Total Score
Measure Description Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.
Time Frame Baseline and 12 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.

Reporting Groups
  Description
Mild Impairment AB+ Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
Mild Impairment AB- Patients diagnosed with a cognitive status of mild impairment and AB- scan result.

Measured Values
   Mild Impairment AB+   Mild Impairment AB- 
Participants Analyzed   178   134 
Change in ADAS-Cog 11 Total Score 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 0.95  (0.38)   1.29  (0.43) 


Statistical Analysis 1 for Change in ADAS-Cog 11 Total Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.568
LS Mean Difference [5] -0.35
95% Confidence Interval -1.54 to 0.84
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change in Patient's Clinical Diagnosis   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Patient's Clinical Diagnosis
Measure Description Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Scan/Diagnosis Discordant Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
Control Scan/Diagnosis Discordant Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis

Measured Values
   Intervention Scan/Diagnosis Discordant   Control Scan/Diagnosis Discordant 
Participants Analyzed   111   109 
Change in Patient's Clinical Diagnosis 
[Units: Percentage of patients]
 85.6   11.9 


Statistical Analysis 1 for Change in Patient's Clinical Diagnosis
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] <0.001
Odds Ratio (OR) [5] 43.9
95% Confidence Interval 20 to 96.12
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change in Diagnostic Confidence   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Diagnostic Confidence
Measure Description Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Scan/Diagnosis Concordant Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
Control Scan/Diagnosis Concordant Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis

Measured Values
   Intervention Scan/Diagnosis Concordant   Control Scan/Diagnosis Concordant 
Participants Analyzed   189   190 
Change in Diagnostic Confidence 
[Units: Percentage Point]
Least Squares Mean (Standard Error)
 23.54  (1.13)   2.85  (1.15) 


Statistical Analysis 1 for Change in Diagnostic Confidence
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.001
LS Mean Difference [5] 20.69
95% Confidence Interval 18.95 to 22.43
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of change in diagnostic confidence at follow-up (3 months)
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change in Patient Management: Advice/Counseling   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Patient Management: Advice/Counseling
Measure Description Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Control Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

Measured Values
   Intervention   Control 
Participants Analyzed   300   299 
Change in Patient Management: Advice/Counseling 
[Units: Percentage of patients]
 64.7   58.9 


Statistical Analysis 1 for Change in Patient Management: Advice/Counseling
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.144
Odds Ratio (OR) [5] 1.28
95% Confidence Interval 0.92 to 1.78
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



6.  Secondary:   Change in Caregiver Self-efficacy   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Caregiver Self-efficacy
Measure Description Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers’ self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Control Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

Measured Values
   Intervention   Control 
Participants Analyzed   301   297 
Change in Caregiver Self-efficacy 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 0.16  (1.24)   0.00  (1.26) 


Statistical Analysis 1 for Change in Caregiver Self-efficacy
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.925
LS Mean Difference [5] 0.16
95% Confidence Interval -3.20 to 3.53
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



7.  Secondary:   Change in Patient Management: Individual Categories   [ Time Frame: Baseline and 3 months ]

Measure Type Secondary
Measure Title Change in Patient Management: Individual Categories
Measure Description Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer’s/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.
Time Frame Baseline and 3 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.

Reporting Groups
  Description
Intervention Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Control Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

Measured Values
   Intervention   Control 
Participants Analyzed   300   299 
Change in Patient Management: Individual Categories 
[Units: Percentage of patients]
   
Major Diagnostic Tests   21   20.4 
Alzheimer's/Cognitive Medication   35.7   22.1 
Neuropsychological Tests   14.7   9.7 
Physician Follow-up for Re-evaluation   15.0   14.0 
Specialist Referral   30.7   23.4 


Statistical Analysis 1 for Change in Patient Management: Individual Categories
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.857
Odds Ratio (OR) [5] 1.04
95% Confidence Interval 0.70 to 1.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Major Diagnostic Tests
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Patient Management: Individual Categories
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] <0.001
Odds Ratio (OR) [5] 1.96
95% Confidence Interval 1.36 to 2.81
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Alzheimer's/Cognitive Medication
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change in Patient Management: Individual Categories
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.063
Odds Ratio (OR) [5] 1.60
95% Confidence Interval 0.97 to 2.64
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Neuropsychological Tests
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Change in Patient Management: Individual Categories
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.741
Odds Ratio (OR) [5] 1.08
95% Confidence Interval 0.69 to 1.70
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Physician Follow-up for Re-evaluation
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Change in Patient Management: Individual Categories
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 0.046
Odds Ratio (OR) [5] 1.45
95% Confidence Interval 1.01 to 2.08
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Specialist Referral
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com



Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01703702     History of Changes
Other Study ID Numbers: 18F-AV-45-A18
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: April 1, 2016
Results First Posted: August 17, 2016
Last Update Posted: August 17, 2016