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A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

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ClinicalTrials.gov Identifier: NCT01992380
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Alzheimer's Disease
Interventions Drug: Flortaucipir F18
Procedure: Brain PET scan
Enrollment 24
Recruitment Details Enrollment between Nov 2013 and May 2014
Pre-assignment Details  
Arm/Group Title Healthy Volunteer Subjects MCI Subjects Probable AD Subjects
Hide Arm/Group Description

Healthy males or females 50 years or older with no evidence of cognitive impairment

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with mild cognitive impairment (MCI)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with probable Alzheimer's Disease (AD)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Period Title: Overall Study
Started 6 8 10
Completed 6 8 10
Not Completed 0 0 0
Arm/Group Title Healthy Volunteer Subjects MCI Subjects Probable AD Subjects Total
Hide Arm/Group Description

Healthy males or females 50 years or older with no evidence of cognitive impairment

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with mild cognitive impairment (MCI)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with probable Alzheimer's Disease (AD)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Total of all reporting groups
Overall Number of Baseline Participants 6 8 10 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 10 participants 24 participants
62.8  (9.5) 70.3  (5.4) 74.4  (7.3) 70.1  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 10 participants 24 participants
Female
4
  66.7%
2
  25.0%
2
  20.0%
8
  33.3%
Male
2
  33.3%
6
  75.0%
8
  80.0%
16
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 10 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
8
 100.0%
10
 100.0%
24
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 10 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
0
   0.0%
1
   4.2%
White
5
  83.3%
8
 100.0%
10
 100.0%
23
  95.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 10 participants 24 participants
6
 100.0%
8
 100.0%
10
 100.0%
24
 100.0%
Mini Mental Status Exam (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 6 participants 8 participants 10 participants 24 participants
29.7  (0.52) 28.3  (1.58) 23.9  (4.58) 26.8  (3.95)
[1]
Measure Description: Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment.
1.Primary Outcome
Title Test-Retest Reproducibility
Hide Description Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Time Frame 80-100 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with a valid test and re-test scan. The 80-100 minute scan was not done for one subject in the healthy volunteer group due to technical difficulties with the scanning apparatus
Arm/Group Title All Subjects
Hide Arm/Group Description:

All study subjects

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: standardized uptake value ratio (SUVr)
Test Imaging Number Analyzed 24 participants
1.342  (0.341)
Retest Imaging Number Analyzed 23 participants
1.355  (0.309)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Subjects
Comments Intraclass correlation coefficient [ICC(2,1)] analysis from Shrout and Fleiss
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ICC
Estimated Value 0.971
Confidence Interval (2-Sided) 95%
0.935 to 0.988
Estimation Comments Assessed the agreement between the test and retest imaging of the combination VOI SUVr
2.Primary Outcome
Title Test-Retest Reproducibility
Hide Description Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Time Frame 110-130 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

All study subjects

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: standardized uptake value ratio (SUVr)
Test Imaging 1.459  (0.455)
Retest Imaging 1.457  (0.396)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Subjects
Comments Intraclass correlation coefficient [ICC(2,1)] analysis from Shrout and Fleiss
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ICC
Estimated Value 0.968
Confidence Interval (2-Sided) 95%
0.926 to 0.986
Estimation Comments Assessed the agreement between the test and retest imaging of the combination VOI SUVr
Time Frame End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Event Reporting Description Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
 
Arm/Group Title Healthy Volunteer Subjects MCI Subjects Probable AD Subjects
Hide Arm/Group Description

Healthy males or females 50 years or older with no evidence of cognitive impairment

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with mild cognitive impairment (MCI)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

Subjects 50 years or older with probable Alzheimer's Disease (AD)

Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan: positron emission tomography (PET) scan of the brain

All-Cause Mortality
Healthy Volunteer Subjects MCI Subjects Probable AD Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/8 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Healthy Volunteer Subjects MCI Subjects Probable AD Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/8 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Healthy Volunteer Subjects MCI Subjects Probable AD Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/8 (0.00%)      3/10 (30.00%)    
Gastrointestinal disorders       
diarrhoea  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders       
dysgeusia  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders       
hypertension  1  0/6 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
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: Medical Director
Organization: Avid Radiopharmaceuticals, Inc.
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01992380    
Other Study ID Numbers: 18F-AV-1451-A03
First Submitted: November 8, 2013
First Posted: November 25, 2013
Results First Submitted: July 16, 2020
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020