CompletedNCT01890343Updated Sep 29, 2014Results posted

Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

A Phase 2 interventional study of florbetapir 18F and 18F-FDG in Alzheimer's Disease and Frontotemporal Dementia, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-29.

Sponsored by Avid Radiopharmaceuticals · Phase 2, Interventional, and Diagnostic

Phase: Phase 2
Study type: Interventional
Enrollment: 34
Allocation: Non-randomized
Ages: 45 Years and older
Sex: All

Study summary

Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).

Conditions studied

Alzheimer's Disease
Frontotemporal Dementia

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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 34 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

AD:

Male or female >= 50 years of age
Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
Have a caregiver who can report on their mental status and activities of daily living (ADL)
Give informed consent or have a caregiver give consent with subject assent.

FTD:

Male or female >= 45 years of age
Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
Give informed consent or have a caregiver give consent with subject assent.

CN:

Male or female >= 45 years of age
Have and MMSE >= 29
Give informed consent

Exclusion criteria

Exclusion Criteria:

Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
Have a recent history of alcohol or substance abuse or dependence
Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Have ever participated in a study with an amyloid targeting agent
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol

Study design

Phase: Phase 2
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 34 participants (actual)

Study arms

Experimental
Frontotemporal Disorder
Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG.
Drug: florbetapir 18F · Drug: 18F-FDG
Experimental
Cognitively Normal
Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Drug: florbetapir 18F
Experimental
Alzheimer's Disease
Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Drug: florbetapir 18F

Interventions

Drugflorbetapir 18F
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Also known as: Florbetapir F 18, 18F-AV-45, Amyvid
Drug18F-FDG
FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
Also known as: FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)

What researchers measure

Primary outcomes

Qualitative Amyloid Image Assessment
Four 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 classification is presented as either positive, negative or tied.
Time frame: 50-60 min after injection
Quantitative Amyloid Image Assessment
The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).
Time frame: 50-60 minutes after injection

Results

Posted Sep 17, 2014

Participant flow

Participant flow — Overall Study
Milestone	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease
Started	8	10	10
Completed	8	10	10
Not completed	0	0	0

Outcome measures

PrimaryQualitative Amyloid Image Assessment

Four 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 classification is presented as either positive, negative or tied.

Time frame:: 50-60 min after injection
Reported as:: Number · participants

Qualitative Amyloid Image Assessment
participants	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease
Positive Scan	2	1	8
Negative Scan	4	8	2
Tie	2	1	0

PrimaryQuantitative Amyloid Image Assessment

The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).

Time frame:: 50-60 minutes after injection
Reported as:: Mean · SUVr

Quantitative Amyloid Image Assessment
SUVr	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease
Quantitative Amyloid Image Assessment	1.25 ± 0.36	1.29 ± 0.11	1.77 ± 0.38

Statistical analysis

Frontotemporal Disorder vs Cognitively Normal vs Alzheimer's Disease · Kruskal-Wallis · p = 0.002

Adverse events

Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Frontotemporal Disorder	—	0/8 (0%)	1/8 (12.5%)
Cognitively Normal	—	0/10 (0%)	0/10 (0%)
Alzheimer's Disease	—	0/10 (0%)	1/10 (10%)

Most frequent other events

Most frequent other events
Event	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease
Neck painMusculoskeletal and connective tissue disorders	1/8	0/10	0/10
NasopharyngitisInfections and infestations	0/8	0/10	1/10

Baseline characteristics

Only subjects who received florbetapir (18F) are included in the baseline analysis population.

Age, Continuous
Age, Continuous(years)	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease	Total
Mean	62.4 ± 9.62	62.4 ± 4.99	62.6 ± 4.35	62.5 ± 6.22

Sex: Female, Male
Sex: Female, Male(Participants)	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease	Total
Female	0	5	3	8
Male	8	5	7	20

Region of Enrollment
Region of Enrollment(participants)	Frontotemporal Disorder	Cognitively Normal	Alzheimer's Disease	Total
United Kingdom	8	10	10	28

Study locations

1 site

Research Site
Manchester, M20 3LJ, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01890343
Lead sponsor: Avid Radiopharmaceuticals
Responsible party: Sponsor
First posted: Jul 1, 2013
Start date: Sep 2009
Primary completion: Dec 2012
Completion: Apr 2013
Results posted: Sep 17, 2014
Last update: Sep 29, 2014

Study contacts

Chief Medical Officer

study director · Avid Radiopharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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