Alzheimer DiseaseISALPNCT01231295
Isotopic Imaging for Prodromal Alzheimer's Disease
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes at 25 sites in France.
Trial summary
The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Alzheimer Disease
- How many people
- 143 participants
- Where
- 25 sitesFrance
- Study dates
- Feb 2011to Sep 2016
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of elderly patients over 70 years of age who consult for memory problems. These patients are further split into two groups based on the clinical validation of memory complaints.
Who may be able to join
- patient consulting for memory problems
- caucasian
- memory complaint is validated by a clinical evaluation
- cognitive performance is sufficiently well preserved so that a diagnostic of dementia cannot be made (according to the DSM-IV-R and NINCDS-ADRDA criteria) at the time of inclusion
- the patient speaks French
- presence of an informant
Show all 14Show fewer
- accepts to sign consent
- Inclusion Criteria for the group without memory problems (reference population):
- at least four years of formal education
- patient consulting for memory problems
- memory problem reported by the patient is not validated by the consultation, nor by the battery of tests specified during screening
- presence of an informant
- Clinical Dementia Rating (CDR) = 0
- accepts to sign consent
Who cannot join
- Instrumental Activities of Daily Living (IADL): at least two items > 1
- Anticholinesterasic treatments and/or memantin before study inclusion
- major depressive syndrome, according to the Global Depressive Scale
- Known neurodegenerative disease or general disease or major physical problems that could interfere with cognitive functioning and testing
- Pathology that might lead to death in the short term (evolving cancer, non stable cardiopathy, hepatic, renal or respiratory insufficiency)
- contra-indications for MRI, PET or SPECT scans
- not affiliated with a social security regimen
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
CHU d'Amiens - Hôpital Sud
Amiens, 80054
CHU d'Angers - Hôtel-Dieu
Angers, 49933
CHU de Besançon - Hôpital Jean Minjoz
Besançon, 25030
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
APHP - Hôpital Albert Chenevier
Créteil, 94010
APHP - Hôpital Charles Foix
Ivry-sur-Seine, 94205
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037
CHRU de Lille - Hôpital Roger Salengro
Lille, 59037
APHP - Hôpital Emile Roux
Limeil-Brévannes, 94456
APHM - Hôpital La Timone Adultes
Marseille, 13385
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
CHU de Nancy - Hôpital Central
Nancy, 54035
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, 06202
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
APHP - Hôpital Lariboisière
Paris, 75010
APHP - Hôpital Broca
Paris, 75013
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
CHU de Poitiers
Poitiers, 86021
CHU de Reims - Hôpital Maison Blanche
Reims, 51092
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
CHRU de Toulouse - Hôpital Garonne
Toulouse, 31059
CHRU de Toulouse - Hôpital Purpan
Toulouse, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, 37044
About this study
Official title: Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease
The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Memory problems | Group with clinically validated memory problems | |
| Reference group | Group without memory problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between AUCs for PET and SPECT imaging
The difference between the AUCs (area under the curve) for PET and SPECT imaging.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Olivier Kotzki, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231295
- Sponsor's protocol ID
- PHRC-N/2009/POK-01
- Other IDs
- 2009-013476-53, 2009
- Acronym
- ISALP
- Status last verified
- Jan 2017
- First submitted
- 29 Oct 2010
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01231295
- Acronym / sponsor ID
- ISALP / PHRC-N/2009/POK-01
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Nov 2010 (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.
The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory problems | – | –Group with clinically validated memory problems |
| Reference group | – | –Group without memory problems |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of elderly patients over 70 years of age who consult for memory problems. These patients are further split into two groups based on the clinical validation of memory complaints.
Key inclusion criteria (14 listed)
- patient consulting for memory problems
- caucasian
- memory complaint is validated by a clinical evaluation
- cognitive performance is sufficiently well preserved so that a diagnostic of dementia cannot be made (according to the DSM-IV-R and NINCDS-ADRDA criteria) at the time of inclusion
- the patient speaks French
Key exclusion criteria (7 listed)
- Instrumental Activities of Daily Living (IADL): at least two items > 1
- Anticholinesterasic treatments and/or memantin before study inclusion
- major depressive syndrome, according to the Global Depressive Scale
- Known neurodegenerative disease or general disease or major physical problems that could interfere with cognitive functioning and testing
- Pathology that might lead to death in the short term (evolving cancer, non stable cardiopathy, hepatic, renal or respiratory insufficiency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference between AUCs for PET and SPECT imaging
Time frame: 1 month
The difference between the AUCs (area under the curve) for PET and SPECT imaging.
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 1 Feb 2017.
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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.
Pierre Olivier Kotzki, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes at 25 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 14 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
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?
The difference between AUCs for PET and SPECT imaging (time frame: 1 month). 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 1 Feb 2017.