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Alzheimer's DiseasePhase 4NCT01703702

Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline

A Phase 4 study testing florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 57 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
florbetapir (18F)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
641 participants
Where
57 sitesin 3 countries
Study dates
Oct 2012to Apr 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be enrolled in the mild impairment (not demented) group if the following criteria are met:
  • Males or females ≥ 50 to <= 90 years of age.
  • Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician.
  • Have a study partner who provides separate consent and is willing to accompany the patient on all of the study visits.
  • Have an MMSE score of 24 to 30 inclusive.
  • Can tolerate a 10-minute PET scan.
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  • Have the ability to cooperate and comply with all study procedures.
  • Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
  • Ability to provide informed consent for study procedures.
  • Patients may be enrolled in the dementia group if the following criteria are met:
  • Are males or females ≥ 50 to <= 90 years of age.
  • Meet clinical criteria for dementia.
  • Have a caregiver who provides separate consent and is willing to accompany the patient on all of the study visits.
  • Have an MMSE score of 16 to 24 inclusive.
  • Have not received a clinical examination and/or laboratory test results that strongly indicates a non-neurodegenerative cause for the patients cognitive impairment.
  • Can tolerate a 10-minute PET scan.
  • Have the ability to cooperate and comply with all study procedures.
  • Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
  • Ability to provide informed consent for study procedures. (If the patient is incapable of giving informed consent, the patient's legal representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).

Who cannot join

  • Patients will be excluded from enrollment if they:
  • Have a current serious or unstable illness;
  • The patient or enrolling physician knows the result of a previous amyloid imaging scan;
  • The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
  • Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
  • Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ -secretase or β -secretase inhibitor) unless it can be documented that the patient received only placebo during the course of the trial;
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  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
  • Patients will also be excluded from enrollment if their enrolling physician:
  • Does not consider Alzheimer's disease as a potential cause of the patient's cognitive decline.
  • Is not the primary physician taking care of the patient with respect to the management of their cognitive impairment.
  • Cannot categorize the patient as either: a) having a documented and completed evaluation for cognitive decline within the past 18 months old; or b) currently undergoing evaluation for cognitive decline.
  • Is unwilling to suspend all testing and other evaluation procedures between the time of the baseline evaluation of the enrolling physician's diagnosis and management plan and the time the completion of the PET scan.

Trial locations and contacts

57 sites in 3 countries.

57 sites in 3 countries

United States21 sites

  • Research Site

    Bennington, Vermont, 05201

  • Research Site

    Boston, Massachusetts, 02115

  • Research Site

    Chestnut Hill, Massachusetts, 02467

  • Research Site

    Clearwater, Florida, 33756

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Greensboro, North Carolina, 27405

  • Research Site

    Las Vegas, Nevada, 89106

  • Research Site

    Las Vegas, Nevada, 89128

  • Research Site

    Miami Beach, Florida, 33140

  • Research Site

    Orlando, Florida, 32806

  • Research Site

    Patchogue, New York, 11772

  • Research Site

    Phoenix, Arizona, 85006

  • Research Site

    Phoenix, Arizona, 85054

  • Research Site

    Providence, Rhode Island, 02903

  • Research Site

    Providence, Rhode Island, 02906

  • Research Site

    Quincy, Massachusetts, 02169

  • Research Site

    Salt Lake City, Utah, 84108

  • Research Site

    Scottsdale, Arizona, 85258

  • Research Site

    Shreveport, Louisiana, 71130

  • Research Site

    Sun City, Arizona, 85351

  • Research Site

    West Palm Beach, Florida, 33407

Other trials in United States

France18 sites

  • Research Site

    Amiens, 80054

  • Research Site

    Bordeaux, 33076

  • Research Site

    Bron, 69500

  • Research Site

    Dijon, 21033

  • Research Site

    Lille, 59037

  • Research Site

    Marseille, 13385

  • Research Site

    Montpellier, 34000

  • Research Site

    Nancy, 54035

  • Research Site

    Nantes, 44093

  • Research Site

    Nice, 06003

  • Research Site

    Paris, 75651

  • Research Site

    Pessac, 33604

  • Research Site

    Reims, 51092

  • Research Site

    Rouen, 76031

  • Research Site

    Strasbourg, 67098

  • Research Site

    Toulouse, 31059

  • Research Site

    Tours, 37044

  • Research Site

    Villeurbanne, 69100

Other trials in France

Italy18 sites

  • Research Site

    Bergamo, 24127

  • Research Site

    Brescia, 20125

  • Research Site

    Brescia, 25123

  • Research Site

    Florence, 50139

  • Research Site

    Genoa, 16128

  • Research Site

    Genoa, 16132

  • Research Site

    Milan, 20122

  • Research Site

    Milan, 20132

  • Research Site

    Milan, 20133

  • Research Site

    Milan, 20162

  • Research Site

    Modena, 41126

  • Research Site

    Monza, 20900

  • Research Site

    Padova, 35128

  • Research Site

    Parma, 43100

  • Research Site

    Perugia, 06132

  • Research Site

    Pisa, 56126

  • Research Site

    Rome, 00133

  • Research Site

    Rome, 00179

Other trials in Italy

About this study

Official title: A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline

This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

Being tested
florbetapir (18F)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • florbetapir (18F)Drug

    Also called 18F-AV-45, florbetapir F 18, AV-45, Amyvid

    Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Study groups in NCT01703702
Study groupRoleWhat they receive
InterventionExperimentalSubjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
Receives: Drug: florbetapir (18F)
ControlExperimentalSubjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Receives: Drug: florbetapir (18F)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical and Diagnostic Change in Patient Management

    Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).

    Measured: Baseline and 3 months

  2. Change in ADAS-Cog 11 Total Score

    Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.

    Measured: Baseline and 12 months

Secondary outcomes (5)

  1. Change in Patient's Clinical Diagnosis

    Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.

    Measured: Baseline and 3 months

  2. Change in Diagnostic Confidence

    Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.

    Measured: Baseline and 3 months

  3. Change in Patient Management: Advice/Counseling

    Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.

    Measured: Baseline and 3 months

  4. Change in Caregiver Self-efficacy

    Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers' self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.

    Measured: Baseline and 3 months

  5. Change in Patient Management: Individual Categories

    Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer's/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01703702
Sponsor's protocol ID
18F-AV-45-A18
Status last verified
Jul 2016
First submitted
5 Oct 2012
Last updated
17 Aug 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 57 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical and Diagnostic Change in Patient Management (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01703702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.

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