Follows older adults with memory complaints to study early Alzheimer's signs
Yearly tests track people with memory complaints for early Alzheimer's disease changes.
Plain-language title generated from the registry record
Registry title: Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
Key facts
- Where
- Paris, FranceSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 70 to 95 who took part in the INSIGHT study and agree to be followed for another 5-6 years with yearly check-ups.
- Age
- 70 to 95 years
- Sex
- All sexes can join.
- Disease stage
- People who earlier took part in the INSIGHT cohort. People with dementia cannot join.
- Earlier treatment
- Must have taken part in the INSIGHT cohort. Cannot have taken part in a trial of an investigational product in the last 30 days before screening.
- Biomarker or test result
- Must be willing and able to have a baseline amyloid PET scan.
Main reasons for not taking part
- Clinical Dementia Rating of 1 or higher at the screening/baseline visit
- Meets research criteria for any type of dementia at screening
- Medical conditions with a long-term risk of memory loss or dementia, such as Parkinson's disease, brain tumor or major depressive disorder
- Serious or unstable illness that could make taking part unsafe
- Cannot have MRI/PET scans, or is allergic to 18F-Florbetapir (Amyvid®)
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 70 and 95 years old?
Source: NCT05806697, who can take part
Where in France
- Hopital Pitie-SalpetriereParis, FranceContact: Stéphanie BomboisTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institut National de la Santé Et de la Recherche Médicale, France
- Trial code
- NCT05806697
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
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.
Inclusion: 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: 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); Clinical Dementia Rating ≥1 at screening/baseline visit only; 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; Hypersensitivity to the active substance or to any of the excipients of 18F-Florbetapir (Amyvid®); 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); Any contraindications for MRI/ PET scan procedure (claustrophobia, ferromagnetic object in the body), to FDG or to 18F-Florbetapir (Amyvid®); 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).