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A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT00702143
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Alzheimer's Disease
Mild Cognitive Impairment
Intervention Drug: florbetapir F 18
Enrollment 184
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AD Subjects MCI Subjects Healthy Controls
Hide Arm/Group Description Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria MCI (mild cognitive impairment) cognitively normal (healthy) controls
Period Title: Overall Study
Started 45 60 79
Completed 45 60 78
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Arm/Group Title AD Subjects MCI Subjects Healthy Controls Total
Hide Arm/Group Description Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria MCI (mild cognitive impairment) cognitively normal (healthy) controls Total of all reporting groups
Overall Number of Baseline Participants 45 60 79 184
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 60 participants 79 participants 184 participants
75.4  (9.21) 71.7  (10.23) 69.4  (11.04) 71.6  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 60 participants 79 participants 184 participants
Female
19
  42.2%
33
  55.0%
45
  57.0%
97
  52.7%
Male
26
  57.8%
27
  45.0%
34
  43.0%
87
  47.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 60 participants 79 participants 184 participants
45 60 79 184
1.Primary Outcome
Title Qualitative Amyloid Image Assessment
Hide Description Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Time Frame 50-60 min after injection
Hide Outcome Measure Data
Hide Analysis Population Description
One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.
Arm/Group Title AD Subjects MCI Subjects Healthy Controls
Hide Arm/Group Description:
Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
MCI (mild cognitive impairment)
cognitively normal (healthy) controls
Overall Number of Participants Analyzed 45 60 78
Measure Type: Number
Unit of Measure: participants
Positive for amyloid 34 23 11
Negative for amyloid 11 37 67
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AD Subjects, MCI Subjects
Comments Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AD Subjects, Healthy Controls
Comments Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MCI Subjects, Healthy Controls
Comments Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Mean Cortical to Cerebellum SUVR
Hide Description Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Time Frame 50-60 min after injection
Hide Outcome Measure Data
Hide Analysis Population Description
One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.
Arm/Group Title AD Subjects MCI Subjects Healthy Controls
Hide Arm/Group Description:
Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
MCI (mild cognitive impairment)
cognitively normal (healthy) controls
Overall Number of Participants Analyzed 45 60 78
Mean (Standard Deviation)
Unit of Measure: SUVR
1.404  (0.2670) 1.199  (0.2761) 1.051  (0.1585)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AD Subjects, MCI Subjects, Healthy Controls
Comments Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AD Subjects, MCI Subjects
Comments Analysis of variance contrast P value testing for difference in the mean cortical SUVR
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AD Subjects, Healthy Controls
Comments Analysis of variance contrast P value testing for difference in the mean cortical SUVR
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MCI Subjects, Healthy Controls
Comments Analysis of variance contrast P value testing for difference in the mean cortical SUVR
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Positive Florbetapir-PET Scans
Hide Description Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.
Time Frame 50-60 min after injection
Hide Outcome Measure Data
Hide Analysis Population Description
One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.
Arm/Group Title AD Subjects MCI Subjects Healthy Controls
Hide Arm/Group Description:
Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
MCI (mild cognitive impairment)
cognitively normal (healthy) controls
Overall Number of Participants Analyzed 45 60 78
Measure Type: Number
Unit of Measure: percentage of amyoid positive scans
75.6 38.3 14.1
Time Frame AEs were collected up to 7 days after injection. SAEs were collected up to 30 days after injection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description All subjects receiving florbetapir F 18 injection
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   1/184 (0.54%)    
Injury, poisoning and procedural complications   
Upper limb fracture † 1  1/184 (0.54%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
All Subjects
Affected / at Risk (%) # Events
Total   2/184 (1.09%)    
Nervous system disorders   
Headache † 1  2/184 (1.09%)  2
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00702143    
Other Study ID Numbers: 18F-AV-45-A05
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: April 6, 2012
Results First Posted: May 3, 2012
Last Update Posted: May 10, 2012