Alzheimer's Disease Clinical Trial
Official title:
Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS)
applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early
Alzheimer's disease (AD).
This study included 15 patients treated with rTMS and whose medication reference is
stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected
in the MCRR of Besançon and the psychiatric department of the University Hospital of
Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using
the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS),
State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety
Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized
by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued
Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test
(STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96),
Rey-complex figure test-copy and Picture naming 80 items test (DO80).
Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25
seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A
psychometric assessment will be conducted again at the end of treatment week and one month
after stopping treatment. A neuropsychometric assessment will be conducted one month after
stopping the treatment. Scales of comfort and acceptability will also be proposed to the
patient to determine whether any gene is caused by this treatment. Moreover a questionnaire
will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and
4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy
Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily
Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of
recent change of the personality (CP6).
The population of this study will be comprised of patients between 60 to 85 years-old with
early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be
recruited on a voluntary basis, after notification and consent in the research center. This
study was conducted over a period of 15 months.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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