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New treatment option for Alzheimer Disease
Official title Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
ClinicalTrials.gov ID: NCT05806697
What this study is testing
What is Blood sampling?
Blood sampling is an investigational medicine, given as a monthly, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 to 95
You may be able to join if
- people 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
You likely can't join if
- 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]...
- Presence of any medical condition associated with a long-term risk of cognitive impairment or dementia including Parkinson's disease, brain tumor...
- Current serious or unstable illnesses (including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic or hematologic...
- 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®).
See the full eligibility criteria
- people 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.
- 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...
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.