Alzheimer's DiseasePhase 2FAIR-ADNCT01325259
FluoroAv45 Imaging Research-in Alzheimer's Disease
A Phase 2 study testing neuropsychologic assessment, [18F]AV-45 PET and 18-FDG PET in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital, Tours at 4 sites in France.
Trial summary
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- neuropsychologic assessment, [18F]AV-45 PET and 18-FDG PET
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2009to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
- 18 < MMS <= 28 for patients
- 28 <= MMS for healthy volunteers
- study period > 7 years
- native language : french
- signed informed consent
- affiliated to a social security system
Who cannot join
- alcoholism in medical history
- diabetes
- arterial hypertension (180/100 and more)
- chronical pulmonary disease with hypoxis
- cranial traumatism with loss of consciousness > 15 minutes
- severe depressive syndrome or anxiety
- psychiatric disease in medical history (excepted simple episodes of depression)
Trial locations and contacts
4 sites in 1 country.
France4 sites
university hospital of CAEN
Caen, 14000
University Hospital of Lille
Lille, 59000
University Hospital of Toulouse
Toulouse, 31000
University Hospital of Tours
Tours, 37000
About this study
Official title: Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.
Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.
Read more
Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.
Method: Prospective multicentric study. 65 patients expected to enter the study.
Primary outcome measure: Standard Uptake Volume ratios.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- neuropsychologic assessment, [18F]AV-45 PET, 18-FDG PET, MRI
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychologic assessmentOther
Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
[18F]AV-45 PETRadiation
intravenous injection of 4 MBq/kg of [18F]AV-45
18-FDG PETRadiation
intravenous injection of 100 to 120 MBq of FDG
MRIOther
Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease | Experimental | 30 patients suffering from Alzheimer's disease Receives: Other: neuropsychologic assessment; Radiation: [18F]AV-45 PET; Radiation: 18-FDG PET; Other: MRI |
| Mild Cognitive Impairment | Experimental | 20 patients suffering from Mild Cognitive Impairment Receives: Other: neuropsychologic assessment; Radiation: [18F]AV-45 PET; Radiation: 18-FDG PET; Other: MRI |
| Control | Experimental | 15 subjects with no cognitive impairment Receives: Other: neuropsychologic assessment; Radiation: [18F]AV-45 PET; Radiation: 18-FDG PET; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value Ratios (SUVr)
Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionDec 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Camus, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325259
- Sponsor's protocol ID
- PHRN08-VC / FAIR AD
- Acronym
- FAIR-AD
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2011
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01325259
- Acronym / sponsor ID
- FAIR-AD / PHRN08-VC / FAIR AD
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.
Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.
Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.
Method: Prospective multicentric study. 65 patients expected to enter the study.
Primary outcome measure: Standard Uptake Volume ratios.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | Experimental | Other: neuropsychologic assessment, Radiation: [18F]AV-45 PET, Radiation: 18-FDG PET, Other: MRI30 patients suffering from Alzheimer's disease |
| Mild Cognitive Impairment | Experimental | Other: neuropsychologic assessment, Radiation: [18F]AV-45 PET, Radiation: 18-FDG PET, Other: MRI20 patients suffering from Mild Cognitive Impairment |
| Control | Experimental | Other: neuropsychologic assessment, Radiation: [18F]AV-45 PET, Radiation: 18-FDG PET, Other: MRI15 subjects with no cognitive impairment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
- 18 < MMS <= 28 for patients
- 28 <= MMS for healthy volunteers
- study period > 7 years
- native language : french
Key exclusion criteria (7 listed)
- alcoholism in medical history
- diabetes
- arterial hypertension (180/100 and more)
- chronical pulmonary disease with hypoxis
- cranial traumatism with loss of consciousness > 15 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychologic assessmentMini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI | Other | Alzheimer's disease, Control, Mild Cognitive Impairment |
| [18F]AV-45 PETintravenous injection of 4 MBq/kg of [18F]AV-45 | Radiation | Alzheimer's disease, Control, Mild Cognitive Impairment |
| 18-FDG PETintravenous injection of 100 to 120 MBq of FDG | Radiation | Alzheimer's disease, Control, Mild Cognitive Impairment |
| MRIMagnetic Resonance Imaging | Other | Alzheimer's disease, Control, Mild Cognitive Impairment |
Primary outcome
Standard Uptake Value Ratios (SUVr)
Time frame: inclusion
Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Camus principal investigator
University Hospital of Tours
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neuropsychologic assessment, [18F]AV-45 PET and 18-FDG PET in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital, Tours at 4 sites in France.
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 7 inclusion and 7 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standard Uptake Value Ratios (SUVr) (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2016.