FindTrial
Sign In

Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02795780
Enrollment
79
Registered
2016-06-10
Start date
2016-08-31
Completion date
2017-08-28
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.

Interventions

DRUGFlortaucipir F18

370 megabecquerel (MBq) IV single-dose

PROCEDUREPET Scan

positron emission tomography (PET) scan

Sponsors

Avid Radiopharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

Exclusion criteria

* Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation * Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session * Have received or participated in a trial with investigational medications in the past 30 days

Design outcomes

Primary

MeasureTime frameDescription
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status18 monthsChange in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.

Countries

United States

Participant flow

Recruitment details

Enrolled between Aug 2016 and Aug 2017. The only subjects eligible were those who completed the Confirmatory Phase of Study A05 (NCT02016560).

Participants by arm

ArmCount
AD Subjects
Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm
25
MCI Subjects
Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm
54
Total79

Baseline characteristics

CharacteristicTotalAD SubjectsMCI Subjects
Age, Continuous73.4 years
STANDARD_DEVIATION 9.54
73.8 years
STANDARD_DEVIATION 10.63
73.2 years
STANDARD_DEVIATION 9.1
Amyloid status
Amyloid Negative
34 Participants6 Participants28 Participants
Amyloid status
Amyloid positive
45 Participants19 Participants26 Participants
CDR-SB3.3 units on a scale
STANDARD_DEVIATION 2.05
4.8 units on a scale
STANDARD_DEVIATION 1.53
2.6 units on a scale
STANDARD_DEVIATION 1.91
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
75 Participants24 Participants51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
MMSE25.2 units on a scale
STANDARD_DEVIATION 2.06
23.7 units on a scale
STANDARD_DEVIATION 2.39
25.9 units on a scale
STANDARD_DEVIATION 1.48
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants0 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
76 Participants25 Participants51 Participants
Region of Enrollment
United States
79 participants25 participants54 participants
Sex: Female, Male
Female
31 Participants9 Participants22 Participants
Sex: Female, Male
Male
48 Participants16 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 540 / 25
other
Total, other adverse events
2 / 540 / 25
serious
Total, serious adverse events
0 / 540 / 25

Outcome results

Primary

Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status

Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.

Time frame: 18 months

Population: Excluded 1 MCI Aβ+ and 1 MCI Aβ- subject for whom 18 month follow-up clinical was not available

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
AD Aβ+ SubjectsChange in Tau Deposition Over Time by Diagnostic Group and Amyloid Status0.0205 standardized uptake value ratio (SUVr)Standard Deviation 0.01871
AD Aβ- SubjectsChange in Tau Deposition Over Time by Diagnostic Group and Amyloid Status-0.0912 standardized uptake value ratio (SUVr)Standard Deviation 0.03619
MCI Aβ+ SubjectsChange in Tau Deposition Over Time by Diagnostic Group and Amyloid Status0.0352 standardized uptake value ratio (SUVr)Standard Deviation 0.01185
MCI Aβ- SubjectsChange in Tau Deposition Over Time by Diagnostic Group and Amyloid Status-0.0124 standardized uptake value ratio (SUVr)Standard Deviation 0.01185
Comparison: Test of whether difference in least squares mean change is 0p-value: 0.0166ANCOVA
Comparison: Test of whether difference in least squares mean change is 0p-value: 0.0108ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026