FLORTAUCIPIR (18F) for Semantic variant primary progressive aphasia | Alcohol use disorder | Organic amnesia syndrome | Narcolepsy | Alzheimer’s disease | Lewy body dementia

Inclusion criteria

• {"criterion_text":"-[all participants] Minimum education level of 7 years (at least equivalent to the French Certificat d’Études Primaires (CEP))\n-[HC] Aged 18 or older\n-[HC] Neuropsychological performance within the normal range for age and education level on all inclusion battery tests (±1.65 standard deviation)\n-[HC] Be considered capable of complying with the protocol according to the investigator's judgment\n-[ATHL] Aged 18 or older\n-[ATHL] Must have participated in a memory competition—international, European, or national level\n-[ATHL] Be considered capable of complying with the protocol according to the investigator's judgment\n-[SCD] Aged 60 or older\n-[SCD] Recruited from memory clinics\n-[SCD] Must meet recognized criteria for subjective cognitive decline in the context of the preclinical stage of Alzheimer’s disease\n-[MCI-AD] Aged 60 or older\n-[all participants] Native French speaker and educated in French\n-[MCI-AD] Recruited from memory clinics\n-[MCI-AD] Must meet current recognized clinical criteria for mild cognitive impairment due to Alzheimer’s disease\n-[D-AD] Aged 60 years or older\n-[D-AD] Recruited from memory clinics\n-[D-AD] Meeting current and recognized clinical criteria for major neurocognitive disorder due to probable Alzheimer’s disease\n-[LBD] Aged 60 years or older\n-[LBD] Recruited from memory clinics\n-[LBD] Meeting current and recognized clinical criteria for probable Lewy body dementia or probable prodromal Lewy body dementia (mild cognitive impairment with Lewy bodies)\n-[svPPA] Aged 50 years or older\n-[svPPA] Recruited from memory clinics\n-[all participants] Affiliated with a French social security scheme or beneficiary of such a scheme\n-[svPPA] Meeting current and recognized clinical criteria for semantic dementia\n-[AUD] Aged 18 years or older\n-[AUD] Recruited from an addiction treatment service\n-[AUD] Undergoing treatment primarily for an alcohol use disorder at the time of inclusion\n-[AUD] Detoxified, with withdrawal symptoms resolved (Cushman score <3, Cushman et al., 1985) and benzodiazepines discontinued at the time of inclusion\n-[AUD] Abstinent from all psychoactive substances (except tobacco and prescribed medication) at the time of inclusion\n-[AMN] Aged 18 years or older\n-[AMN] Recruited from hospital services or residential facilities housing patients with non-degenerative amnesic syndromes\n-[AMN] Presenting with major cognitive impairment : Characterized primarily by severe episodic memory deficits (anterograde amnesia), possibly associated with retrograde amnesia and/or other impairments ;\tLeading to significant impacts on daily functioning and reduced autonomy ;\tPersistent and stable over time\n-[NARCO] Aged 18 years or older\n-[all participants] Willingness to undergo several days of assessments\n-[NARCO] -\tDiagnosed with type 1 narcolepsy according to the 3rd edition of the International Classification of Sleep Disorders (ICSD-3), which includes daytime sleepiness persisting for more than 3 months, and either : Presence of cataplexy, mean sleep latency <8 minutes on the Multiple Sleep Latency Test (MSLT), and at least two REM sleep onsets (on MSLT and/or overnight polysomnography) ; Or cerebrospinal fluid hypocretin level <110 pg/mL.\n-[Informant] Aged 18 years or older\n-[Informant] Spending at least one day per week with a relative included in one of the patient groups\n-[all participants] Adherence to lifestyle considerations\n-[all participants] Signed informed consent to participate in the study\n-[ACT] Aged 18 or older\n-[ACT] Must have performed in at least one theatre play in the last three years\n-[ACT] Must be or have been a professional actor, either freelance or permanent (e.g., in a theatre company or at the Comédie-Française) for at least 5 years"}

Exclusion criteria

• {"criterion_text":"-[all participants except informants] Pregnant or breastfeeding women\n-[all participants except informants] Chronic use of medications that affect cognition and/or may interfere with cognitive or imaging assessments (including non-tricyclic antidepressants, anticonvulsants such as lamotrigine, pregabalin, levetiracetam ; atypical antipsychotics; short-/intermediate-acting benzodiazepines such as alprazolam, lorazepam, oxazepam, temazepam; and sedative antihistamines), if doses were not stabilized within the 6 weeks prior to inclusion (except for changes due to withdrawal treatment in AUD patients)\n-[all participants except informants] Current use of long-acting benzodiazepines, typical antipsychotics, tricyclic antidepressants, or first-generation antihistamines at the time of inclusion (unless related to withdrawal treatment in AUD patients), with discontinuation of such medication less than 3 months prior to inclusion\n-[all participants except informants] Physical, behavioral, or geographical limitations preventing participation in the study\n-[all participants except informants] Refusal to cooperate during assessments\n-[HC] Current or recent (within the last 5 years) theater practice\n-[HC] Presence of depressive symptoms (MADRS score > 19, threshold for moderate depression)\n-[ACT & ATHL] Presence of depressive symptoms (MADRS score > 19, threshold for moderate depression)\n-[ACT & ATHL] Use of Alzheimer’s disease medications (including but not limited to donepezil, rivastigmine, galantamine, and memantine) at non-stabilized doses within 8 weeks prior to the inclusion visit\n-[SCD] Presence of depressive symptoms (MADRS score > 34, threshold for severe depression)\n-[MCI-AD] Presence of depressive symptoms (MADRS score > 34, threshold for severe depression)\n-[MCI-AD] Use of Alzheimer’s disease medications (including but not limited to donepezil, rivastigmine, galantamine, and memantine) at non-stabilized doses within 8 weeks prior to the inclusion visit\n-[D-AD, LBD & svPPA] Presence of depressive symptoms (MADRS score > 34, threshold for severe depression)\n-[D-AD, LBD & svPPA] Absence of a caregiver or informant (i.e., a trusted person or relative who will be present from inclusion through the assessments, for patients with major cognitive impairment)\n-[D-AD, LBD & svPPA] Use of Alzheimer’s disease medications (including but not limited to donepezil, rivastigmine, galantamine, and memantine) and/or L-DOPA for LBD patients, at non-stabilized doses within 8 weeks prior to the inclusion visit\n-[D-AD, LBD & svPPA] Inability to understand instructions\n-[AUD & AMN] Presence of depressive symptoms (MADRS score > 34, threshold for severe depression)\n-[AUD & AMN] Evidence suggesting a probable neurodegenerative disorder (e.g., impairment in instrumental cognitive functions)\n-[all participants except informants] Known hypersensitivity to Amyvid® or Tauvid®\n-[all participants except informants] Participation in a clinical study involving exposure to ionizing radiation within the year prior to inclusion\n-[all participants except informants] Current participation in a clinical trial and/or other research involving human participants (RIPH) if it includes imaging examinations using radiotracers\n-[all participants except informants] History of neurological or neurosurgical conditions that could significantly affect cognitive function and/or neuroimaging (e.g., head trauma with loss of consciousness >30 minutes, stroke, multiple sclerosis, insulin coma)\n-[all participants except informants] Schizophrenia, psychotic disorders, or bipolar disorders (according to DSM-5 criteria)\n-[all participants except informants] Having a score suggesting an alcohol dependence (>9) on the FACE questionnaire (except for AUD patients)"}

Primary endpoints

• {"endpoint_text":"-[Part 2 - Objective 1] Volume measurements (from T1 MRI) and perfusion measurements (from early-phase Amyvid® PET) in the 4 brain networks in each patient group and in controls","definition_or_measurement_approach":"Volume measurements derived from T1 MRI; perfusion measurements derived from early-phase Amyvid® PET as stated in the endpoint text."}

Secondary endpoints

• {"endpoint_text":"-[Part 1 - Objective 1] Number of participants having successfully completed all examinations necessary for the evaluation of the main judgement criterion of CIRAANO","definition_or_measurement_approach":""}
• {"endpoint_text":"-[Part 1 - Objective 2] Score obtained on the acceptability scale","definition_or_measurement_approach":""}
• {"endpoint_text":"-Behavioral data collected using the various questionnaires","definition_or_measurement_approach":""}
• {"endpoint_text":"-Raw scores from neuropsychological tests","definition_or_measurement_approach":""}
• {"endpoint_text":"-Scores from the directed forgetting task (number of “To Remember” and “To Forget” words identified as new or previously seen)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Composite scores by cognitive function and domain (lifestyle factors, sleep, psycho-affective or subjective evaluation) assessed by neuropsychological tests and questionnaires. Composite scores correspond to an average of standardized z-scores, calculated from the raw scores collected in the control group for the corresponding function (scores presenting a normal distribution and without floor/ceiling effects)","definition_or_measurement_approach":"Composite scores = average of standardized z-scores calculated from control group raw scores (for normally distributed scores without floor/ceiling effects)."}
• {"endpoint_text":"-Ranking position in the national memory sports classification (for the memory athlete group)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Theater experience and practice, in terms of time and number of plays learned (for the actor group)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Gray matter volume measured in each voxel of the brain","definition_or_measurement_approach":""}
• {"endpoint_text":"-Volume of the hippocampus and hippocampal subfields","definition_or_measurement_approach":""}
• {"endpoint_text":"-Volume of the thalamus and thalamic subregions","definition_or_measurement_approach":""}
• {"endpoint_text":"-Mean intensity value of the locus coeruleus","definition_or_measurement_approach":""}
• {"endpoint_text":"-Cerebral perfusion measured in each voxel of the brain","definition_or_measurement_approach":""}
• {"endpoint_text":"-Fractional anisotropy, mean diffusivity, and mean kurtosis in each voxel of the brain","definition_or_measurement_approach":""}
• {"endpoint_text":"-Number, size, and location of white matter lesions","definition_or_measurement_approach":""}
• {"endpoint_text":"-Functional brain connectivity","definition_or_measurement_approach":""}
• {"endpoint_text":"-Beta-amyloid burden (from the radiopharmaceutical Amyvid®) measured in each voxel of the brain and overall mean in gray matter","definition_or_measurement_approach":"Measured using Amyvid® PET imaging; voxelwise and overall mean in gray matter as specified."}
• {"endpoint_text":"-Burden of neurofibrillary tangles or abnormally phosphorylated Tau protein (from the radiopharmaceutical Tauvid®) measured in each voxel of the brain and overall mean in the temporal region","definition_or_measurement_approach":"Measured using Tauvid® PET imaging; voxelwise and overall mean in the temporal region as specified."}
• {"endpoint_text":"-Brain activity measured by fMRI specifically associated with recall, encoding, and learning from the text learning task (compared to activity measured during control tasks of reading and verbal articulation)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Data collected during EEG recording associated with the passive listening task of auditory stimuli","definition_or_measurement_approach":""}
• {"endpoint_text":"-Spontaneous oscillatory activity (EEG) in a resting state","definition_or_measurement_approach":""}
• {"endpoint_text":"-Subjective sleep measures collected through sleep questionnaires","definition_or_measurement_approach":""}
• {"endpoint_text":"-Data collected through actigraphy","definition_or_measurement_approach":""}
• {"endpoint_text":"-Data collected through polysomnographic recordings","definition_or_measurement_approach":""}
• {"endpoint_text":"-Data collected through the SomnoArt® device","definition_or_measurement_approach":""}
• {"endpoint_text":"-Blood measures","definition_or_measurement_approach":""}
• {"endpoint_text":"-Anthropometric and physical measures (from the medical interview, ECG analysis from polysomnographic recording during a wakeful state)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Measurement of liver fibrosis using Fibroscan®","definition_or_measurement_approach":""}
• {"endpoint_text":"-Scores from questionnaires and information about the relative (age, type of relationship with the participant, frequency of meetings, number of years of relationship) provided by the accompanying persons/informants depending on the participant’s group","definition_or_measurement_approach":""}

Methods

• Recruited from memory clinics (for SCD, MCI-AD, D-AD, LBD, svPPA groups)
• Recruited from addiction treatment services (for AUD group)
• Recruitment of memory athletes via memory competitions (international, European, or national level) or equivalent performance criteria
• Recruitment of theatre actors via theatre practice/companies (must have performed in at least one theatre play in last three years and professional practice ≥5 years)
• Informants/relevant relatives recruited by being relatives who spend at least one day per week with a patient included in a patient group

France

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

11

Number Of Sites

6

Number Of Participants

600

Primary sponsor

Full Name

Institut National De La Sante Et De La Recherche Medicale

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Petnet Solutions S.A.S.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Curium Pet France","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}