Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study

Last updated: January 21, 2025
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Problems

Mild Cognitive Impairment

Treatment

18F-fluorodeoxyglucose (FDG) PET Scan

18-F amyloid PET Scan

Blood sampling

Clinical Study ID

NCT05806697
C20-70
  • Ages 70-95
  • All Genders

Study 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

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 andhas to be able to provide accurate information, at least by phone, about theparticipants' cognitive and functional abilities.

Exclusion

Exclusion Criteria:

  • Clinical Dementia Rating ≥1 at screening/baseline visit only

  • Fulfilling research diagnostic criteria for any type of dementia-related disorder atscreening visit (clinical AD, Dementia with Lewy Bodies [DLB], fronto-temporaldementia [FTD], vascular dementia, chronic traumatic encephalopathy [CTE],Limbic-predominant Age-related TDP-43 Encephalopathy [LATE], Primary age-relatedtauopathy [PART)

  • Presence of any medical condition associated with a long-term risk of cognitiveimpairment or dementia including Parkinson's disease, brain tumor, subduralhematoma, vascular malformations, territorial stroke (excluding smaller watershedstrokes), chronic hydrocephalus, traumatic brain injury with neurological sequelae,active alcohol/drug abuse, major depressive disorder, schizophrenia and bipolardisorder

  • Current serious or unstable illnesses (including cardiovascular, hepatic, renal,gastroenterologic, respiratory, endocrinologic or hematologic disease) that mightmake the subject's participation in an investigational trial unsafe

  • Any contraindications for MRI/ PET scan procedure (claustrophobia, ferromagneticobject 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 30days before the screening (during all study duration co-inclusion in other clinicaltrial of an investigational product or observational research [biomarker cohorte.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).

Study Design

Total Participants: 240
Treatment Group(s): 7
Primary Treatment: 18F-fluorodeoxyglucose (FDG) PET Scan
Phase:
Study Start date:
April 14, 2023
Estimated Completion Date:
October 09, 2030

Connect with a study center

  • Hôpital Pitié Salpêtrière

    Paris, Ile de france 75013
    France

    Active - Recruiting

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