Trial Outcomes & Findings for 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) (NCT NCT00702143)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

184 participants

Primary outcome timeframe

50-60 min after injection

Results posted on

2012-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	AD Subjects 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 Subjects MCI (mild cognitive impairment)	Healthy Controls cognitively normal (healthy) controls
Overall Study STARTED	45	60	79
Overall Study COMPLETED	45	60	78
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AD Subjects 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 Subjects MCI (mild cognitive impairment)	Healthy Controls cognitively normal (healthy) controls
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AD Subjects n=45 Participants 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 Subjects n=60 Participants MCI (mild cognitive impairment)	Healthy Controls n=79 Participants cognitively normal (healthy) controls	Total n=184 Participants Total of all reporting groups
Age Continuous	75.4 years STANDARD_DEVIATION 9.21 • n=93 Participants	71.7 years STANDARD_DEVIATION 10.23 • n=4 Participants	69.4 years STANDARD_DEVIATION 11.04 • n=27 Participants	71.6 years STANDARD_DEVIATION 10.57 • n=483 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	33 Participants n=4 Participants	45 Participants n=27 Participants	97 Participants n=483 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	27 Participants n=4 Participants	34 Participants n=27 Participants	87 Participants n=483 Participants
Region of Enrollment United States	45 participants n=93 Participants	60 participants n=4 Participants	79 participants n=27 Participants	184 participants n=483 Participants

PRIMARY outcome

Timeframe: 50-60 min after injection

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AD Subjects n=45 Participants 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 Subjects n=60 Participants MCI (mild cognitive impairment)	Healthy Controls n=78 Participants cognitively normal (healthy) controls
Qualitative Amyloid Image Assessment Positive for amyloid	34 participants	23 participants	11 participants
Qualitative Amyloid Image Assessment Negative for amyloid	11 participants	37 participants	67 participants

PRIMARY outcome

Timeframe: 50-60 min after injection

Population: 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.

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=45 Participants 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 Subjects n=60 Participants MCI (mild cognitive impairment)	Healthy Controls n=78 Participants cognitively normal (healthy) controls
Mean Cortical to Cerebellum SUVR	1.404 SUVR Standard Deviation 0.2670	1.199 SUVR Standard Deviation 0.2761	1.051 SUVR Standard Deviation 0.1585

SECONDARY outcome

Timeframe: 50-60 min after injection

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AD Subjects n=45 Participants 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 Subjects n=60 Participants MCI (mild cognitive impairment)	Healthy Controls n=78 Participants cognitively normal (healthy) controls
Proportion of Positive Florbetapir-PET Scans	75.6 percentage of amyoid positive scans Interval 60.5 to 87.1	38.3 percentage of amyoid positive scans Interval 26.1 to 51.8	14.1 percentage of amyoid positive scans Interval 7.3 to 23.8

Adverse Events

All Subjects

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=184 participants at risk All subjects receiving florbetapir F 18 injection
Injury, poisoning and procedural complications Upper limb fracture	0.54% 1/184 • Number of events 1 • AEs were collected up to 7 days after injection. SAEs were collected up to 30 days after injection.

Other adverse events

Other adverse events
Measure	All Subjects n=184 participants at risk All subjects receiving florbetapir F 18 injection
Nervous system disorders Headache	1.1% 2/184 • Number of events 2 • AEs were collected up to 7 days after injection. SAEs were collected up to 30 days after injection.

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60