Actively Recruiting
Investigation of Alzheimer's Predictors in People with Memory Complaints An Extension Study with Annual Evaluations Over 5 to 6 Years
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-01-23
240
Participants Needed
1
Research Sites
390 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are continuing to follow participants who were previously involved in the INSIGHT study to better understand the development of preclinical Alzheimer's disease. This regional, single-center, prospective observational study will track subjects aged 70 to 95 years for an additional 5 to 6 years. The main focus is on identifying when participants progress to symptomatic Alzheimer's disease, particularly those at risk due to positive amyloid deposits detected by florbetapir PET imaging. The study plans to include about 240 participants from the original 318, with a lighter follow-up schedule of annual visits instead of every six months. During the study, participants will undergo several evaluations including cognitive and oculomotor tests, blood sampling, lumbar puncture, MRI scans at baseline and at months 12, 36, and 60, as well as PET scans with 18F-Florbetapir to detect amyloid and 18F-fluorodeoxyglucose for brain metabolism. An EEG will be performed only if a participant shows significant cognitive decline or converts to symptomatic Alzheimer's disease. These procedures aim to monitor the natural course of the disease and related brain changes. Participants will be involved in yearly assessments over a five-year period to track changes in cognition and brain function, including neuroimaging and biological sampling. Researchers will evaluate the conversion to symptomatic Alzheimer's disease as the primary outcome. Safety monitoring and data collection will continue throughout the study duration to understand disease progression better and to ensure participant well-being.
CONDITIONS
Official Title
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously participated in the INSIGHT cohort
- Aged between 70 and 95 years
- Signed informed consent
- Willing and able to undergo baseline PET amyloid imaging
- Affiliated with the French health-care system
- Has an identified informant with sufficient contact able to provide accurate cognitive and functional information about the participant
You will not qualify if you...
- Clinical Dementia Rating of 1 or higher at screening or baseline
- Diagnosed with any type of dementia-related disorder at screening
- Presence of medical conditions linked to long-term risk of cognitive impairment or dementia such as Parkinson's disease, brain tumor, subdural hematoma, vascular malformations, territorial stroke, chronic hydrocephalus, traumatic brain injury with neurological effects, active alcohol or drug abuse, major depressive disorder, schizophrenia, or bipolar disorder
- Serious or unstable illnesses that could make participation unsafe
- Contraindications for MRI or PET scans (claustrophobia, ferromagnetic implants) or to FDG or 18F-Florbetapir
- Hypersensitivity to 18F-Florbetapir or its excipients
- Participation in any investigational product clinical trial within 30 days before screening
- Unable to comply with study protocol as judged by the investigator
- Under guardianship (safeguard of justice, curatorship, or guardianship)
- Living in a skilled nursing facility or nursing home (EHPAD)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Pitié Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
Research Team
N
Nadjia YOUNSI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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