- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01554202
Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)
Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging
According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.
Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.
The three main objectives of this project are
- to identify, compare and combine predictive markers of Alzheimer's disease
- to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
- to study the ability of different neuroimaging techniques to follow the evolution of this pathology.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Caen, Francia, 14033
- University Hospital Côte de Nacre
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Lille, Francia, 59037
- University Hospital Roger Salengro
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Rennes, Francia, 35033
- University Hospital Pontchaillou
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Rouen, Francia, 76031
- University Hospital Rouen
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Tours, Francia, 37044
- university hospital Tours
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Education level > 7 years
- Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
- Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).
Exclusion Criteria:
- The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
- A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
- A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
- A medication that may interfere with memory or metabolic measures
- A alcohol or drugs abuse
- claustrophobia, metallic object in the body
- A predominantly left-hand (score below 50% in Edinburgh Inventory).
- Protected adults, and persons not affiliated with a social security system will not participate in this study.
- The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Middle age controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Elderly controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Autosomal dominant forms of early-onset Alzheimer disease
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Subjectif Cognitive Impariment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Mild Cognitive Impairment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Alzheimer Disease patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Non degenerative amnsesic syndrome
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Sperimentale: Frontotemporal lobe dementia
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Tasso di variazione del volume dell'intero cervello, dell'ippocampo e di altre misure MRI strutturali
Lasso di tempo: 3 anni
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3 anni
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Tasso di declino misurato da: test cognitivi, attività della vita quotidiana e somma dei riquadri CDR
Lasso di tempo: 3 anni
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3 anni
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Tassi di variazione su ciascun biomarcatore biochimico specificato
Lasso di tempo: 3 anni
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3 anni
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Tassi di variazione del metabolismo del glucosio (FDG-PET)
Lasso di tempo: 3 anni
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3 anni
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Entità della deposizione di amiloide misurata da 18F-AV45
Lasso di tempo: 3 anni
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3 anni
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Differenze di gruppo per ciascuna misurazione di imaging e biomarcatore
Lasso di tempo: 3 anni
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3 anni
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Genotipo APOE
Lasso di tempo: 3 anni
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3 anni
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.
- Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.
- La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.
- Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2007-A00414-49
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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