ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)
Enrollment 641
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Intervention Control
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 308 310
Completed 272 288
Not Completed 36 22
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 308 310 618
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants 310 participants 618 participants
73.1  (8.2) 72.7  (7.94) 72.9  (8.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 310 participants 618 participants
Female
142
  46.1%
160
  51.6%
302
  48.9%
Male
166
  53.9%
150
  48.4%
316
  51.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 308 participants 310 participants 618 participants
United States 112 111 223
Italy 109 112 221
France 87 87 174
1.Primary Outcome
Title Clinical and Diagnostic Change in Patient Management
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Overall Number of Participants Analyzed 300 299
Measure Type: Number
Unit of Measure: percentage of patients
68.0 55.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.22 to 2.38
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in ADAS-Cog 11 Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.
Arm/Group Title Mild Impairment AB+ Mild Impairment AB-
Hide Arm/Group Description:
Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
Overall Number of Participants Analyzed 178 134
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.95  (0.38) 1.29  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Impairment AB+, Mild Impairment AB-
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-1.54 to 0.84
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Patient's Clinical Diagnosis
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Scan/Diagnosis Discordant Control Scan/Diagnosis Discordant
Hide Arm/Group Description:
Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
Overall Number of Participants Analyzed 111 109
Measure Type: Number
Unit of Measure: percentage of patients
85.6 11.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Scan/Diagnosis Discordant, Control Scan/Diagnosis Discordant
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 43.9
Confidence Interval (2-Sided) 95%
20 to 96.12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Diagnostic Confidence
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Scan/Diagnosis Concordant Control Scan/Diagnosis Concordant
Hide Arm/Group Description:
Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
Overall Number of Participants Analyzed 189 190
Least Squares Mean (Standard Error)
Unit of Measure: Percentage Point
23.54  (1.13) 2.85  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Scan/Diagnosis Concordant, Control Scan/Diagnosis Concordant
Comments Comparison of change in diagnostic confidence at follow-up (3 months)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 20.69
Confidence Interval (2-Sided) 95%
18.95 to 22.43
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Patient Management: Advice/Counseling
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Overall Number of Participants Analyzed 300 299
Measure Type: Number
Unit of Measure: percentage of patients
64.7 58.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.92 to 1.78
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Caregiver Self-efficacy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Overall Number of Participants Analyzed 301 297
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.16  (1.24) 0.00  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-3.20 to 3.53
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Patient Management: Individual Categories
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Overall Number of Participants Analyzed 300 299
Measure Type: Number
Unit of Measure: 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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Major Diagnostic Tests
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.857
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.70 to 1.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Alzheimer's/Cognitive Medication
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
1.36 to 2.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Neuropsychological Tests
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.97 to 2.64
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Physician Follow-up for Re-evaluation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.69 to 1.70
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Specialist Referral
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.01 to 2.08
Estimation Comments [Not Specified]
Time Frame 48 hours post-injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Population
Hide Arm/Group Description 620 patients received florbetapir (18F) and comprise the Safety Population.
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Population
Affected / at Risk (%) # Events
Total   2/620 (0.32%)    
Injury, poisoning and procedural complications   
Subdural haematoma * 1  1/620 (0.16%)  1
Nervous system disorders   
Cerebral haemorrhage * 1  1/620 (0.16%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Population
Affected / at Risk (%) # Events
Total   36/620 (5.81%)    
Cardiac disorders   
Palpitations * 1  1/620 (0.16%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/620 (0.16%)  1
Gastrointestinal disorders   
Nausea * 1  4/620 (0.65%)  4
Abnormal faeces * 1  1/620 (0.16%)  1
General disorders   
Asthenia * 1  3/620 (0.48%)  3
Fatigue * 1  3/620 (0.48%)  3
Feeling abnormal * 1  1/620 (0.16%)  1
Malaise * 1  1/620 (0.16%)  1
Infections and infestations   
Upper respiratory tract infection * 1  1/620 (0.16%)  1
Injury, poisoning and procedural complications   
Post procedural haematoma * 1  1/620 (0.16%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/620 (0.16%)  1
Myalgia * 1  1/620 (0.16%)  1
Nervous system disorders   
Headache * 1  17/620 (2.74%)  17
Dizziness * 1  1/620 (0.16%)  1
Psychiatric disorders   
Confusional state * 1  1/620 (0.16%)  1
Hallicination, olfactory * 1  1/620 (0.16%)  1
Insomnia * 1  1/620 (0.16%)  1
Irritability * 1  1/620 (0.16%)  1
Sleep disorder * 1  1/620 (0.16%)  1
Renal and urinary disorders   
Dysuria * 1  1/620 (0.16%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  1/620 (0.16%)  1
Vascular disorders   
Flushing * 1  1/620 (0.16%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
Phone: 215-298-0700
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