Trial Outcomes & Findings for Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline (NCT NCT01703702)
NCT ID: NCT01703702
Last Updated: 2016-08-17
Results Overview
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).
COMPLETED
PHASE4
641 participants
Baseline and 3 months
2016-08-17
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
308
|
310
|
|
Overall Study
COMPLETED
|
272
|
288
|
|
Overall Study
NOT COMPLETED
|
36
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline
Baseline characteristics by cohort
| Measure |
Intervention
n=308 Participants
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
n=310 Participants
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
n=618 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 7.94 • n=7 Participants
|
72.9 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
111 participants
n=7 Participants
|
223 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
109 participants
n=5 Participants
|
112 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Region of Enrollment
France
|
87 participants
n=5 Participants
|
87 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
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).
Outcome measures
| Measure |
Intervention
n=300 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=299 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Clinical and Diagnostic Change in Patient Management
|
68.0 percentage of patients
|
55.5 percentage of patients
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.
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.
Outcome measures
| Measure |
Intervention
n=178 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=134 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in ADAS-Cog 11 Total Score
|
0.95 units on a scale
Standard Error 0.38
|
1.29 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=111 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=109 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in Patient's Clinical Diagnosis
|
85.6 percentage of patients
|
11.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=189 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=190 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in Diagnostic Confidence
|
23.54 Percentage Point
Standard Error 1.13
|
2.85 Percentage Point
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
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.
Outcome measures
| Measure |
Intervention
n=300 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=299 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in Patient Management: Advice/Counseling
|
64.7 percentage of patients
|
58.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
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.
Outcome measures
| Measure |
Intervention
n=301 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=297 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in Caregiver Self-efficacy
|
0.16 units on a scale
Standard Error 1.24
|
0.00 units on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.
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.
Outcome measures
| Measure |
Intervention
n=300 Participants
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
|
Control
n=299 Participants
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
|
|---|---|---|
|
Change in Patient Management: Individual Categories
Major Diagnostic Tests
|
21 percentage of patients
|
20.4 percentage of patients
|
|
Change in Patient Management: Individual Categories
Alzheimer's/Cognitive Medication
|
35.7 percentage of patients
|
22.1 percentage of patients
|
|
Change in Patient Management: Individual Categories
Neuropsychological Tests
|
14.7 percentage of patients
|
9.7 percentage of patients
|
|
Change in Patient Management: Individual Categories
Physician Follow-up for Re-evaluation
|
15.0 percentage of patients
|
14.0 percentage of patients
|
|
Change in Patient Management: Individual Categories
Specialist Referral
|
30.7 percentage of patients
|
23.4 percentage of patients
|
Adverse Events
Safety Population
Serious adverse events
| Measure |
Safety Population
n=620 participants at risk
620 patients received florbetapir (18F) and comprise the Safety Population.
|
|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
Other adverse events
| Measure |
Safety Population
n=620 participants at risk
620 patients received florbetapir (18F) and comprise the Safety Population.
|
|---|---|
|
Vascular disorders
Flushing
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Cardiac disorders
Palpitations
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Nervous system disorders
Headache
|
2.7%
17/620 • Number of events 17 • 48 hours post-injection
|
|
Nervous system disorders
Dizziness
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
General disorders
Asthenia
|
0.48%
3/620 • Number of events 3 • 48 hours post-injection
|
|
General disorders
Fatigue
|
0.48%
3/620 • Number of events 3 • 48 hours post-injection
|
|
General disorders
Feeling abnormal
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
General disorders
Malaise
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Psychiatric disorders
Confusional state
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Psychiatric disorders
Hallicination, olfactory
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Psychiatric disorders
Insomnia
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Psychiatric disorders
Irritability
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Psychiatric disorders
Sleep disorder
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Gastrointestinal disorders
Nausea
|
0.65%
4/620 • Number of events 4 • 48 hours post-injection
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Renal and urinary disorders
Dysuria
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/620 • Number of events 1 • 48 hours post-injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60