Clinical trial NCT05806697: Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
Official title: Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Memory Complaint
Memory Disorders
Keywords: risks factors
brain amyloid load
neurosciences
neurology
memory complaint
memory disorders
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 70
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: The primary endpoint is the conversion to typical AD during the 5-year follow-up.
timeFrame: every year through study completion, from baseline for 5 years (M60)
Secondary outcomes:
measure: Change in Clinical Dementia Rating- Sum of Boxes (CDR-SB) score compared to baseline
timeFrame: Each 1 year from baseline for 5 years (M60)
measure: Change in different neuroimaging, biological, electrophysiological and oculomotor parameters compared to baseline
timeFrame: Each 1 year from baseline for 5 years (M60)
measure: Change of the score in different self-administered, informant based questionnaires (including the Quality Of Life (QOL), Ascertain Dementia 8 (AD)8 Dementia Screening Interview, Aging Brain Care Monitor)
timeFrame: Each 1 year from baseline for 5 years (M60)
measure: Rate of change in biomarkers measured from blood, CSF, structural and functional neuroimaging (MRI), EEG and molecular neuroimaging (18F-FDG-PET and amyloid imaging)
timeFrame: Each 1 year from baseline for 5 years (M60)
measure: Conversion to symptomatic non-AD cognitive disease
timeFrame: Each 1 year from baseline for 5 years (M60)
measure: Diagnosis of cerebral amyloid angiopathy based on V2.0 BOSTON criteria
timeFrame: Each 1 year from baseline for 5 years (M60)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
state: Ile de france
Study officials:
affiliation: Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
name: Stéphanie BOMBOIS, MD
role: PRINCIPAL_INVESTIGATOR
References: