Alzheimer Disease Clinical Trial
Official title:
Novel Tailored Network-based rTMS Treatments in Alzheimer's Disease: an Integrated Multiimaging Approach
Severe alterations of brain networks connectivity have been described in Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained evidence as an effective tool to modulate brain networks connectivity, leading to a recovery or reorganization of both local and remote brain regions functionally connected to the stimulated area. The investogators propose an innovative tailored network-based rTMS treatment to ameliorate cognitive symptoms in mild AD, through the boosting of connectivity within brain networks affected by AD pathophysiology. The combination of the proposed intervention with an integrated multi-modal imaging approach will allow to evaluate the neural mechanisms underlying the clinical response to the treatment and to define quantitative markers of clinical impact on AD. If successful, the present proposal would immediately impact on patient's quality of life, with important implications for the time and costs of delivery of rehabilitative services.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 21, 2024 |
Est. primary completion date | September 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility | Inclusion Criteria: - Mini-Mental State Examination score >=16, <=24 - Anti-cholinesterase treatment for at least 3 months prior the start date Exclusion Criteria: - Enrollment in other clinical and pharmacological trials - Previous evidence of any other CNS disorder (e.g. epilepsy, infectious diseases, frontotemporal, Parkinson or Pick's disease) - History of major psychiatric disorders - History of alchol or substance abuse - Stress-related skin problems - Current consumption of psychiatric medication - Presence of metal implants or any implanted electronics |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Centro San Giovanni di Dio Fatebenefratelli | Brescia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Centro San Giovanni di Dio Fatebenefratelli | I.R.C.C.S. Fondazione Santa Lucia, Ministero della Salute, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in ADAS-Cog scale scores | A brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia | At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2) | |
Secondary | Change in CANTAB battery scores | The scores on two tests of CANTAB battery (www.cambridgecognition.com):
Change in Associative Learning test (PAL) Change in Spatial Working Memory test (SWM) |
At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2) | |
Secondary | Change in brain connectivity | TMS-evoked cortical responses (TEPs) will serve as markers of reactivity of the stimulated area as well as markers of the connectivity between targeted cortex and functionally connected areas underlying DMN or CEN. | At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2) | |
Secondary | Change in brain plasticity | A theta burst stimulation (TBS) protocol will be used to probe plasticity changes | At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2) | |
Secondary | Change in MRI measures of functional and structural connectivity | At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2) |
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