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Highlighting the benefits of walking sessions in a therapeutic garden in patients with Alzheimer's disease by PET / CT imaging of the brain with a radiopharmaceutical: 18F-FDG

Phase 1
Conditions
atients followed at the Memory and Research Center (CMRR) and diagnosed with mild to moderate Alzheimer's disease (MMS 15-23)
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2020-001025-31-FR
Lead Sponsor
CHRU Nancy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
25
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

• 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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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