Trial Outcomes & Findings for A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD) (NCT NCT01662882)

Last Updated: 2013-09-19

Results Overview

Five 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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

48 participants

Primary outcome timeframe

50-60 min after injection

Results posted on

2013-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	MCI Subjects MCI (mild cognitive impairment) florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Overall Study STARTED	15	18	15
Overall Study COMPLETED	15	18	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AD Subjects n=15 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Healthy Controls n=18 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	MCI Subjects n=15 Participants MCI (mild cognitive impairment) florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Total n=48 Participants Total of all reporting groups
Age Continuous	73.3 participants STANDARD_DEVIATION 7.80 • n=5 Participants	70.0 participants STANDARD_DEVIATION 11.15 • n=7 Participants	73.3 participants STANDARD_DEVIATION 5.09 • n=5 Participants	72.1 participants STANDARD_DEVIATION 8.57 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment Japan	15 participants n=5 Participants	18 participants n=7 Participants	15 participants n=5 Participants	48 participants n=4 Participants

PRIMARY outcome

Timeframe: 50-60 min after injection

Outcome measures

Outcome measures
Measure	AD Subjects n=15 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	MCI Subjects n=15 Participants MCI (mild cognitive impairment) florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Healthy Controls n=18 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Qualitative Amyloid Image Assessment Positive for amyloid	12 participants	5 participants	3 participants
Qualitative Amyloid Image Assessment Negative for amyloid	3 participants	10 participants	15 participants

PRIMARY outcome

Timeframe: 50-60 min after injection

Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Outcome measures

Outcome measures
Measure	AD Subjects n=15 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	MCI Subjects n=15 Participants MCI (mild cognitive impairment) florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Healthy Controls n=18 Participants florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Mean Cortical to Cerebellum SUVR	1.271 SUVR Standard Deviation 0.182	1.112 SUVR Standard Deviation 0.197	1.022 SUVR Standard Deviation 0.220

Adverse Events

AD Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MCI Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AD Subjects n=15 participants at risk florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	MCI Subjects n=15 participants at risk MCI (mild cognitive impairment) florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose	Healthy Controls n=18 participants at risk florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Investigations Blood pressure increased	0.00% 0/15	6.7% 1/15 • Number of events 1	5.6% 1/18 • Number of events 1
General disorders Fatigue	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
General disorders Malaise	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
General disorders Vessel puncture site pain	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
Eye disorders Vision blurred	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Nausea	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15	6.7% 1/15 • Number of events 1	0.00% 0/18
Nervous system disorders Headache	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/15	0.00% 0/15	5.6% 1/18 • Number of events 1

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60