Hôpital Pitié Salpêtrière
Paris, Île-de-France Region, 75013, France
Location status: Recruiting
Location contact
Nadjia YOUNSI
CONTACT
Stéphanie Bombois
CONTACT
NCT Number: NCT05806697
A regional, single-center, prospective, observational academic cohort will follow subjects who previously participated in the INSIGHT study and who agree an extension of their follow-up in the INSIGHT-2 research for additional 5-6 years. An annual multimodal evaluation (cognitive, oculomotor, biological and neuroimaging) will be proposed in order to describe the natural history of preclinical Alzheimer's disease (AD). The primary endpoint is the conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir positron emission tomography (PET) imaging. The size of the cohort is estimated to around 240 participants (61 A+ subjects) among the 318 participants included in the main cohort (88 A+ subjects). The follow-up in the INSIGHT-2 cohort will be lightened compared to that of the main cohort with an annual frequency of visits rather than a six-monthly one.
Interested in participating?
Request Info70 year–95 year
All sexes
Interventional
Not applicable
Paris, Île-de-France Region, 75013, France
Location status: Recruiting
Nadjia YOUNSI
CONTACT
Stéphanie Bombois
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The EEG will be uniquely performed during for the whole study if a given subject converts to symptomatic AD or in the occurrence of significant cognitive decline.
All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders.
All INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60.
The primary endpoint is conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir PET imaging. Participants will receive an injection of 18F-Florbetapir prior to undergoing amyloid PET scanning. Florbetapir (18F) is an experimental imaging compound labeled with [18F] fluorine that decays by positron (β+) emission and has a half-life of 109.77 min. This procedure will be done at baseline.
Participants will receive an injection of Fludeoxyglucose 18F prior to undergoing FDG-PET. The [18F]FDG is the most well-known radiopharmaceutical positron emitter, in both clinical and preclinical fields.
A total of 80 ml of whole blood will be collected for each participant in the INSIGHT-2 study for routine laboratory assessment and biobank sampling.
A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants.
Time frame: every year through study completion, from baseline for 5 years (M60)
Typical AD according to International Working Group (IWG) 2014 criteria = amyloid-positive participants, with an abnormal decline of episodic memory performance on the Free and Cued Selective Reminding Test
Time frame: Each 1 year from baseline for 5 years (M60)
CDR-SB : Hughes, Br J Psychiatry 1982; 140: 566-72
Time frame: Each 1 year from baseline for 5 years (M60)
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Atypical AD according to IWG 2014 criteria
Time frame: Each 1 year from baseline for 5 years (M60)
As described in the following reference: Charidimou et al., Lancet Neurol. 2022 Aug;21(8):714-725
Contact information is provided by the study sponsor or research team.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: INSIGHT-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05709210
Alzheimer Disease, Brain Diseases
Poitiers, France
View Trial DetailsNCT07645638
Alzheimer Disease, Brain Diseases
Burgos, Spain
View Trial DetailsNCT05364307
Alzheimer Disease, Brain Diseases
San Diego, California, United States
View Trial DetailsNCT02843529
Alzheimer Disease, Asymptomatic Diseases
View Trial Details