atients followed at the Memory and Research Center (CMRR) and diagnosed with mild to moderate Alzheimer's disease (MMS 15-23)
Conditions
Interventions
Trade Name: FLUCIS
Product Name: FLUCIS
Pharmaceutical Form: Solution for injection
Trade Name: GLUCOTEP
Product Name: GLUCOTEP
Pharmaceutical Form: Solution for injection
Sponsors
CHRU Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient with AD at the light to moderate stage, followed at the CMRR (MMS 15-23) and having benefited during their diagnostic care from a PET / CT scan at 18F-FDG having a companion for the duration of the study . • Patient with a neuropsychological assessment (MOCA, DO80, BREF, HAD) of less than 3 months. (If the last neuropsychological assessment was more than 3 months ago, these tests are performed in routine care during the consultation during which the study will be offered and consent obtained) • Symptomatic treatment of AD (anticholinesterase or memantine) if prescribed, at a stable dose for 1 month, stable psychotropic treatment for 1 month • Person affiliated with a social security scheme or beneficiary of such a scheme. • Patient over 18 years old. • Person having received complete information on the organization of the research and having signed their informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Impairment of understanding interfering with participation in the protocol (score> 2 of the MMS comprehension test at inclusion) • Patient who did not have biomarkers identified by lumbar puncture • Patient unable to perform a cerebral PET scan with 18F-FDG (maintaining a lying position for more than 20 minutes) • Patient unable to follow the therapeutic program of the garden. • Woman of childbearing age who does not have effective contraception. • Pregnant woman or nursing mother. • Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code. • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of the use of the Therapeutic Garden by people living with Alzheimer's disease on the carbohydrate metabolism in cerebral PET / CT with 18F-FDG.;Secondary Objective: 1. Evaluate the impact of the use of the Alzheimer Therapeutic Garden (JAZ program) on carbohydrate metabolism in cerebral PET / CT with 18F-FDG using the actimetry parameter as a covariate in the model. 2. Evaluate the impact of the use of the Therapeutic Garden on people living with Alzheimer's disease on the self-awareness questionnaire (QCS). 3. Correlate the metabolism of the brain regions with the clinical variables (neuropsychological assessment, QCS) before and after using the therapeutic garden. 4. Evaluate the impact of the use of the therapeutic garden on the electrodermal response (RED).;Primary end point(s): Topography of brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after using the Therapeutic Garden;Timepoint(s) of evaluation of this end point: 1 months after inlcusion of the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1 months after inclusion of each patient, we will have all information to evaluate this secondary end points;Secondary end point(s): 1. Topography of the brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after the use of the Therapeutic Garden by people living with Alzheimer's disease by integrating the actimetry as co-variable in the model. 2. Comparison of QCS before and after using the therapeutic garden 3. Topography of brain regions, whose carbohydrate metabolism covariates with clinical variables (neuropsychological assessment, QCS). 4. Modifications of the RED score during the use of the garden | — |
Countries
France
Contacts
Public ContactAnne-Sophie Hue
CHRU Nancy
Outcome results
None listed