Brief description of trial (Data source: BASEC)
Notre étude clinique vise à étudier l’effet de la radiothérapie dans le traitement de la maladie d’Alzheimer.
La participation est ouverte à toutes les personnes de plus de 65 ans, qui souffrent de troubles cognitifs liés à la maladie d’Alzheimer au stade précoce. L'étude se déroule dans les Services de Radio-Oncologie, de Médecine Nucléaire et à la Consultation de la Mémoire des Hôpitaux Universitaires de Genève (HUG). Elle comprendra au total 20 patients (les patients seront affectés aléatoirement à un groupe des 2 groupes de l’étude : traitement par radiothérapie ou suivi habituel) et chacun sera suivi pendant environ 16 mois . L'étude durera 2 ans au total.
Health conditions investigated(Data source: BASEC)
Maladie d'Alzeimer
Health conditions
(Data source: WHO)
Alzheimer Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Radiothérapie à faible dose sur le cerveau de personnes souffrant de la maladie d'Alzheimer.
Interventions
(Data source: WHO)
Radiation: Low dose radiotherapy
Criteria for participation in trial
(Data source: BASEC)
-être agé(e) de plus de 65 ans et pouvoir donner son consentement
-avoir la maladie d'Alzheimer
-Avoir un PET/CT au 18F- Florbétapir positif et datant de moins de 8 semaines
Exclusion criteria
(Data source: BASEC)
- être inclus dans un autre essai clinique modifiant la maladie
- avoir déjà reçu une irradiation du cerveau
– avoir une maladie oncologique active ou en rémission depuis moins de 5 ans
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Ability to understand the clinical trial and give an informed consent
- Clinical diagnosis of prodromal AD, or mild or moderate AD
- Ability to undergo neurocognitive assessment at baseline visit, alone or accompanied
by a caregiver
- Amyloid PET scan positivity
- Ability to follow the 5-days RT regiment, alone or accompanied by a caregiver
Exclusion Criteria:
- Inclusion in another disease modifying clinical trial
- Previous therapeutic brain irradiation
- Evidence of vascular cognitive impairment on Magnetic Resonance Imaging (MRI) (Fazekas
score >1 and Wahlund score >=10/30)
- Oncologic disease (excluding skin cancer) active or in remission from less than 5
years
- Evidence of substance abuse (alcohol and/or other drugs) with a dependence during the
previous 12 months (DSM-IV criteria)
- Presence of subdural hygroma's, subdural hematomas or hydrocephalus
- Significant psychiatric comorbidity as assessed during the clinical evaluation by the
neurologist/geriatrician in charge
- Active or recent (within 3 months) cerebral infection/haemorrhage
- Immunocompromised status
- Prior history of seizure
- Dermatological skin disease of the scalp
- Women who are pregnant or breast feeding or who intend to become pregnant during the
course of the study;
- Lack of safe contraception, defined as: female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases;
-
Further information on trial
Date trial registered
Nov 20, 2017
Incorporation of the first participant
Nov 17, 2017
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Safety and adverse event associated with low dose brain RT;Change in brain amyloid deposits
Secundary end point
(Data source: WHO)
Neuropsychological performances
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
Undecided
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Geneva
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Pr. Valentina Garibotto
+41 79 55 34 459
Valentina.Garibotto@hcuge.ch
Contact for general information
(Data source: WHO)
Thomas Zilli, Dr.
University Hospital, Geneva
+ 41 79 55 32 563
thomas.zilli@hcuge.ch
Contact for scientific information
(Data source: WHO)
Thomas Zilli, Dr.
University Hospital, Geneva
+ 41 79 55 32 563
thomas.zilli@hcuge.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission Cantonale
d’éthique de la recherche Genève (CCER)
Date of authorisation by the ethics committee
16.11.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-01715
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