Investigation of Alzheimer's predictors in people with memory complaints
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
NA · Institut National de la Santé Et de la Recherche Médicale, France · NCT05806697
This study is trying to see if people with memory problems and positive amyloid tests will develop Alzheimer's disease over the next few years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 70 Years to 95 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT05806697 on ClinicalTrials.gov |
What this trial studies
This study is a regional, single-center, prospective, observational cohort that will follow subjects who previously participated in the INSIGHT study for an additional 5-6 years. Participants will undergo annual multimodal evaluations, including cognitive assessments, oculomotor tests, biological evaluations, and neuroimaging to track the natural history of preclinical Alzheimer's disease. The primary goal is to observe the conversion to symptomatic Alzheimer's in individuals identified as at risk through positive amyloid PET imaging. The cohort is expected to include around 240 participants, with a focus on those showing amyloid positivity.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 70 to 95 who previously participated in the INSIGHT cohort and are willing to undergo PET amyloid imaging.
Not a fit: Patients with a clinical dementia rating of 1 or higher or those diagnosed with any type of dementia-related disorder will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and understanding of Alzheimer's disease, potentially leading to better management strategies for at-risk individuals.
How similar studies have performed: Other studies have shown success in using amyloid PET imaging to identify at-risk populations for Alzheimer's, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects that previously participated in the INSIGHT cohort * Aged 70 to 95 years old * Having signed an informed consent * Willing to and able undergo a baseline PET amyloid imaging * Affiliating to the French health-care system * Having an identified informant who has sufficient contact with the participant and has to be able to provide accurate information, at least by phone, about the participants' cognitive and functional abilities. Exclusion Criteria: * Clinical Dementia Rating ≥1 at screening/baseline visit only * Fulfilling research diagnostic criteria for any type of dementia-related disorder at screening visit (clinical AD, Dementia with Lewy Bodies \[DLB\], fronto-temporal dementia \[FTD\], vascular dementia, chronic traumatic encephalopathy \[CTE\], Limbic-predominant Age-related TDP-43 Encephalopathy \[LATE\], Primary age-related tauopathy \[PART) * Presence of any medical condition associated with a long-term risk of cognitive impairment or dementia including Parkinson's disease, brain tumor, subdural hematoma, vascular malformations, territorial stroke (excluding smaller watershed strokes), chronic hydrocephalus, traumatic brain injury with neurological sequelae, active alcohol/drug abuse, major depressive disorder, schizophrenia and bipolar disorder * Current serious or unstable illnesses (including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic or hematologic disease) that might make the subject's participation in an investigational trial unsafe * Any contraindications for MRI/ PET scan procedure (claustrophobia, ferromagnetic object in the body), to FDG or to 18F-Florbetapir (Amyvid®). * Hypersensitivity to the active substance or to any of the excipients of 18F-Florbetapir (Amyvid®). * Participation in any clinical trial of an investigational product in the last 30 days before the screening (during all study duration co-inclusion in other clinical trial of an investigational product or observational research \[biomarker cohort e.g.\] will be possible but the information would need to be recorded). * Unable to comply with protocol requirements in the opinion of the investigator * Being under guardianship (safeguard of justice, curatorship or guardianship) * Residence in skilled nursing facility, including nursing homes (EHPAD).
Where this trial is running
Paris, Île-de-France Region
- Hôpital Pitié Salpêtrière — Paris, Île-de-France Region, France (RECRUITING)
Study contacts
- Principal investigator: Stéphanie BOMBOIS, MD — Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
- Study coordinator: Nadjia YOUNSI
- Email: nadjia.younsi@icm-institute.org
- Phone: +331 42 16 75 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Memory Complaint, Memory Disorders, risks factors, brain amyloid load, neurosciences, neurology, memory complaint