Trial Outcomes & Findings for Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals (NCT NCT00855868)

Results Overview

Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

28 d

Results posted on

2012-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Alzheimer's Disease Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90	Healthy Controls Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
Overall Study STARTED	13	15
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alzheimer's Disease n=13 Participants Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90	Healthy Controls n=15 Participants Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.	Total n=28 Participants Total of all reporting groups
Age Continuous	69.8 years STANDARD_DEVIATION 9.88 • n=5 Participants	71.5 years STANDARD_DEVIATION 9.23 • n=7 Participants	70.7 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 d

Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

Outcome measures

Outcome measures
Measure	Alzheimer's Disease n=12 Participants Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90	Healthy Controls n=14 Participants Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. Frontal cortex to cerebellum SUVR	1.33 SUVR Standard Deviation .20	1.00 SUVR Standard Deviation .18
Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. Whole brain to cerebellum SUVR	1.38 SUVR Standard Deviation .15	1.06 SUVR Standard Deviation .17

Adverse Events

Alzheimer's Disease

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Alzheimer's Disease n=13 participants at risk Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90	Healthy Controls n=15 participants at risk Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
Eye disorders Visual Disturbance	7.7% 1/13 • Number of events 1	0.00% 0/15
General disorders Injection Site Pain	7.7% 1/13 • Number of events 1	0.00% 0/15
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1	0.00% 0/15
Nervous system disorders Headache	7.7% 1/13 • Number of events 1	0.00% 0/15
Vascular disorders Hypertension	0.00% 0/13	6.7% 1/15 • Number of events 1

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