Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02164643 |
| Other study ID # |
CHUBX 2010/47 A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2014 |
| Est. completion date |
October 9, 2019 |
Study information
| Verified date |
February 2022 |
| Source |
University Hospital, Bordeaux |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A Multicenter national longitudinal cohort study including at least 800 individuals
consecutively recruited from French Research Memory Centers and followed-up over 24 month and
included in Memento.
Description:
Alzheimer's disease (AD) is the most common cause of dementia in the elderly, affecting
approximately 7.3 million people in Europe. AD is a clinicopathologic entity for which the
definitive diagnosis requires both the presence of the clinical signs of dementia and
pathological evidence of amyloid plaque in the brain (obtained at autopsy).
Currently, diagnosis of AD at early stage of the disease is hampered by the lack of
noninvasive and validated biomarkers of the underlying pathology. On one hand, it is
suggested that between 10% and 20% of patients currently diagnosed with AD, based on clinical
evidence solely, lack AD pathology at autopsy, and on the other hand community physicians may
not diagnose AD in 33% of patients with mild signs and symptoms. Thus, there is a need for
validated diagnostic biomarker that could help clinicians separate patients who do not have
AD from those who have pathological signs and should be referred for further evaluation and
care management. Furthermore, little is known on the prognosis value for dementia conversion
of current biomarkers of AD pathology at a preclinical or presymptomatic stage.
Recently, 18F-labeled positron emission tomography (PET) imaging agents have been developed
that bind with high affinity to the amyloid-β (Aβ) peptide fibrils that constitute amyloid
plaques, and thus, have potential value as an imaging biomarkers for amyloid deposits in
subjects with cognitive impairment or isolated cognitive complaints.
The principal objective of this ancillary study is to investigate the prospective association
between PET amyloid load, measured twice two years apart, through either Florbetapir (18F) or
Flutemetamol (18F) radioligands, and dementia incidence over up to 5 years of follow-up in a
sample of individuals presenting with a spectrum of cognitive profiles ranging from isolated
cognitive complaints to cognitive deficits without dementia.
The secondary objectives are the following:
- To assess the association between change in amyloid load and clinical evolution of
participants (both functional and cognitive)
- To estimate the prevalence of new research criteria for preclinical Alzheimer's disease
- To investigate long-term outcome of preclinical Alzheimer's disease according to NIA-AA
criteria
- To assess the determinants of change in amyloid load over two years
- To study the interrelationships between biomarkers
- To assess the added value of amyloid binding agent (Florbetapir (18F) and Flutemetamol
(18F)) in combination with other biomarkers (neuropsychological, genetics, plasma,
serum, CSF, structural neuroimaging, 18F-FDG-PET) to predict clinical dementia onset
- To assess the diagnostic accuracy of amyloid agent Florbetapir (18F) and Flutemetamol
(18F) to differentiate AD from other types of dementia (differential diagnosis)
- To study the link between amyloid binding agent and survivalstudy design
