Actively Recruiting
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
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
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.
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Pitié Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
Research Team
N
Nadjia YOUNSI
CONTACT
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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