Alzheimer DiseaseINSIGHT-2NCT05806697
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
A study testing Electroencephalogram (EEG), Oculomotor tests and MRI in people with Alzheimer Disease and Memory Complaint, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 95 years
- Conditions the study is for
- Alzheimer Disease, Memory Complaint, Memory Disorders
- What is being tested?
- Electroencephalogram (EEG), Oculomotor tests and MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2023to 9 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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®).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpêtrière
Paris, Île-de-France Region, 75013
Stéphanie Bombois, +33142167515, stephanie.bombois@aphp.fr
Nadjia YOUNSI, +33142167515, nadjia.younsi@icm-institute.org
About this 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.
- Conditions
- Alzheimer Disease, Memory Complaint, Memory Disorders
- Being tested
- Electroencephalogram (EEG), Oculomotor tests, MRI, 18-F amyloid PET Scan, 18F-fluorodeoxyglucose (FDG) PET Scan
- Keywords
- risks factors, brain amyloid load, neurosciences, neurology, memory complaint, memory disorders
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG)Procedure or surgery
The EEG will be uniquely performed during for the whole study if a given subject converts to symptomatic AD or in the occurrence of significant cognitive decline.
Oculomotor testsProcedure or surgery
All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders.
MRIProcedure or surgery
All INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60.
18-F amyloid PET ScanRadiation
The primary endpoint is conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir PET imaging. Participants will receive an injection of 18F-Florbetapir prior to undergoing amyloid PET scanning. Florbetapir (18F) is an experimental imaging compound labeled with [18F] fluorine that decays by positron (β+) emission and has a half-life of 109.77 min. This procedure will be done at baseline.
18F-fluorodeoxyglucose (FDG) PET ScanRadiation
Participants will receive an injection of Fludeoxyglucose 18F prior to undergoing FDG-PET. The [18F]FDG is the most well-known radiopharmaceutical positron emitter, in both clinical and preclinical fields.
Blood samplingBiological
A total of 80 ml of whole blood will be collected for each participant in the INSIGHT-2 study for routine laboratory assessment and biobank sampling.
Lumbar punctureBiological
A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Not described Receives: Procedure: Electroencephalogram (EEG); Procedure: Oculomotor tests; Procedure: MRI; Radiation: 18-F amyloid PET Scan; Radiation: 18F-fluorodeoxyglucose (FDG) PET Scan; Biological: Blood sampling; Biological: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the conversion to typical AD during the 5-year follow-up.
Typical AD according to International Working Group (IWG) 2014 criteria = amyloid-positive participants, with an abnormal decline of episodic memory performance on the Free and Cued Selective Reminding Test
Measured: every year through study completion, from baseline for 5 years (M60)
Secondary outcomes (6)
Change in Clinical Dementia Rating- Sum of Boxes (CDR-SB) score compared to baseline
CDR-SB : Hughes, Br J Psychiatry 1982; 140: 566-72
Measured: Each 1 year from baseline for 5 years (M60)
Change in different neuroimaging, biological, electrophysiological and oculomotor parameters compared to baseline
Exploratory outcomes
Measured: Each 1 year from baseline for 5 years (M60)
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)
Exploratory outcomes
Measured: Each 1 year from baseline for 5 years (M60)
Rate of change in biomarkers measured from blood, CSF, structural and functional neuroimaging (MRI), EEG and molecular neuroimaging (18F-FDG-PET and amyloid imaging)
Exploratory outcomes
Measured: Each 1 year from baseline for 5 years (M60)
Conversion to symptomatic non-AD cognitive disease
Atypical AD according to IWG 2014 criteria
Measured: Each 1 year from baseline for 5 years (M60)
Diagnosis of cerebral amyloid angiopathy based on V2.0 BOSTON criteria
As described in the following reference: Charidimou et al., Lancet Neurol. 2022 Aug;21(8):714-725
Measured: Each 1 year from baseline for 5 years (M60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start14 Apr 2023
- Primary completion9 Oct 2030 (estimated)
- Study completion9 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stéphanie BOMBOIS, MD, Principal investigator, Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806697
- Sponsor's protocol ID
- C20-70
- Acronym
- INSIGHT-2
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
- ClinicalTrials.gov ID
- NCT05806697
- Acronym / sponsor ID
- INSIGHT-2 / C20-70
- Conditions
- Alzheimer Disease, Memory Complaint, Memory Disorders
- Keywords
- risks factors, brain amyloid load, neurosciences, neurology, memory complaint, memory disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 9 Oct 2030 (estimated)
- Study completion
- 9 Oct 2030 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Procedure: Electroencephalogram (EEG), Procedure: Oculomotor tests, Procedure: MRI, Radiation: 18-F amyloid PET Scan, Radiation: 18F-fluorodeoxyglucose (FDG) PET Scan, Biological: Blood sampling, Biological: Lumbar puncture |
Who may qualify
- Ages
- 70 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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®).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroencephalogram (EEG)The EEG will be uniquely performed during for the whole study if a given subject converts to symptomatic AD or in the occurrence of significant cognitive decline. | Procedure or surgery | All participants |
| Oculomotor testsAll participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders. | Procedure or surgery | All participants |
| MRIAll INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60. | Procedure or surgery | All participants |
| 18-F amyloid PET ScanThe primary endpoint is conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir PET imaging. Participants will receive an injection of 18F-Florbetapir prior to undergoing amyloid PET scanning. Florbetapir (18F) is an experimental imaging compound labeled with [18F] fluorine that decays by positron (β+) emission and has a half-life of 109.77 min. This procedure will be done at baseline. | Radiation | All participants |
| 18F-fluorodeoxyglucose (FDG) PET ScanParticipants will receive an injection of Fludeoxyglucose 18F prior to undergoing FDG-PET. The [18F]FDG is the most well-known radiopharmaceutical positron emitter, in both clinical and preclinical fields. | Radiation | All participants |
| Blood samplingA total of 80 ml of whole blood will be collected for each participant in the INSIGHT-2 study for routine laboratory assessment and biobank sampling. | Biological | All participants |
| Lumbar punctureA lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants. | Biological | All participants |
Primary outcome
The primary endpoint is the conversion to typical AD during the 5-year follow-up.
Time frame: every year through study completion, from baseline for 5 years (M60)
Typical AD according to International Working Group (IWG) 2014 criteria = amyloid-positive participants, with an abnormal decline of episodic memory performance on the Free and Cued Selective Reminding Test
6 secondary outcomes
Change in Clinical Dementia Rating- Sum of Boxes (CDR-SB) score compared to baseline
Time frame: Each 1 year from baseline for 5 years (M60)
Change in different neuroimaging, biological, electrophysiological and oculomotor parameters compared to baseline
Time frame: Each 1 year from baseline for 5 years (M60)
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)
Time frame: Each 1 year from baseline for 5 years (M60)
Rate of change in biomarkers measured from blood, CSF, structural and functional neuroimaging (MRI), EEG and molecular neuroimaging (18F-FDG-PET and amyloid imaging)
Time frame: Each 1 year from baseline for 5 years (M60)
Conversion to symptomatic non-AD cognitive disease
Time frame: Each 1 year from baseline for 5 years (M60)
Diagnosis of cerebral amyloid angiopathy based on V2.0 BOSTON criteria
Time frame: Each 1 year from baseline for 5 years (M60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie BOMBOIS, MD principal investigator
Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram (EEG), Oculomotor tests and MRI in people with Alzheimer Disease and Memory Complaint, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadjia YOUNSI (+331 42 16 75 15, nadjia.younsi@icm-institute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the conversion to typical AD during the 5-year follow-up. (time frame: every year through study completion, from baseline for 5 years (M60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.