Trial Outcomes & Findings for Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD (NCT NCT02681172)

Last Updated: 2018-11-02

Results Overview

The Physician's diagnosis was assessed before and after FBB PET scan. The initial Physician's diagnosis was collected before the PET scan, at Visit 1, based on key diagnostic results of current or previous workup. After the PET scan, the final Physician's diagnosis was collected at Visit 3, based on the amyloid PET scan results.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

218 participants

Primary outcome timeframe

Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

Results posted on

2018-11-02

Participant Flow

This was a Phase IV, multi-center study which was conducted in an outpatient setting documenting routine clinical care in the Centres Mémoire Ressources et Recherches (CMRR). Subjects were recruited in 18 active centers in France.

Participant milestones

Participant milestones
Measure	Neuraceq (Florbetaben 18F) PET Scan A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. PET: A brain PET scan was taken 90 minutes after the i.v. injection of florbetaben 18F.
Overall Study STARTED	218
Overall Study Safety Analysis Set	205
Overall Study Full Analysis Set	205
Overall Study Per Protocol Set	205
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuraceq (Florbetaben 18F) PET Scan n=205 Participants A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. PET: A brain PET scan was taken 90 minutes after the i.v. injection of florbetaben 18F.
Age, Continuous	70.9 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	102 Participants n=93 Participants
Sex: Female, Male Male	103 Participants n=93 Participants

PRIMARY outcome

Timeframe: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

Population: All subjects who received any amount of florbetaben were included in the Safety analysis set

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes	137 Participants

SECONDARY outcome

Timeframe: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

The Physician's diagnostic confidence was rated on a five-point Likert scale before and after FBB PET scan. Likert scales consisted of the categories: "very weak", "weak", "moderate", "high", and "very high".

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3	167 Participants

SECONDARY outcome

Timeframe: Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)

Population: All subjects who received any amount of florbetaben were included in the Safety analysis set.

For all subjects, concomitant medications were reported and any change of the management plan (e.g. new medications initiated, medications withdrawn, additional diagnostic tests ordered, referred to another specialist) was noted.

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes	164 Participants

SECONDARY outcome

Timeframe: Visit 3 (up to 6 months after baseline evaluation)

PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either "positive" or "negative" according to the approved visual assessment method.

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects With Positive FBB PET Scan	132 Participants

SECONDARY outcome

Timeframe: Visit 3 (up to 6 months after baseline evaluation)

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects With Negative FBB PET Scans	73 Participants

SECONDARY outcome

Timeframe: Visit 1 (baseline evaluation)

Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects With Contraindicated or Failed Lumbar Puncture	45 Participants

SECONDARY outcome

Timeframe: Visit 1 (baseline evaluation)

Non-contributory CSF results (ambiguous CSF result, CSF result inconsistent with clinical information, uninterpretable CSF result for technical reasons)

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician	87 Participants

SECONDARY outcome

Timeframe: Visit 1 (baseline evaluation)

Outcome measures

Outcome measures
Measure	Safety Analysis Set n=205 Participants All subjects who received any amount of florbetaben were included.
Number of Subjects Who Refused Lumbar Puncture.	75 Participants

Adverse Events

Safety Analysis Set

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Analysis Set n=205 participants at risk All subjects who received any amount of florbetaben were included.
Nervous system disorders Cerebellar infarct	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.

Other adverse events

Other adverse events
Measure	Safety Analysis Set n=205 participants at risk All subjects who received any amount of florbetaben were included.
Eye disorders Glaucoma	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Gastrointestinal disorders Nausea	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
General disorders Fatigue	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
General disorders Inflammation	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
General disorders Injection Site Haematoma	0.98% 2/205 • Number of events 2 • Adverse events were captured for up to 7 days after the PET scan procedure.
General disorders Injection Site Pain	2.0% 4/205 • Number of events 4 • Adverse events were captured for up to 7 days after the PET scan procedure.
General disorders Injection Site Paraesthesia	2.4% 5/205 • Number of events 5 • Adverse events were captured for up to 7 days after the PET scan procedure.
Metabolism and nutrition disorders Dehydration	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Nervous system disorders Cerebellar infarction	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Nervous system disorders Headache	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Psychiatric disorders Confusional State	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Renal and urinary disorders Acute Kidney injury	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Skin and subcutaneous tissue disorders Erythema	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Skin and subcutaneous tissue disorders Pruritus	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Skin and subcutaneous tissue disorders Skin Ulcer	0.49% 1/205 • Number of events 1 • Adverse events were captured for up to 7 days after the PET scan procedure.
Surgical and medical procedures Cataract operation	0.49% 1/205 • Number of events 2 • Adverse events were captured for up to 7 days after the PET scan procedure.

Additional Information

Dr. Juergen Hirschfeld, Head of GRA & PV

Piramal Imaging

Phone: +49 30461124615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place