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According to the most popular pathophysiological models of Alzheimer's disease, the amyloid hypothesis, amyloid deposition is the causative event triggering a chain of other downstream events which finally lead to Alzheimer's disease and dementia. In mouse models of Alzheimer's disease, 40 Hz multi-sensory (auditory and visual) stimulation was able to reduce the number and size of amyloid plaques throughout cortex and improve cognitive performance.
The primary objective of this study is to assess whether an intervention consisting of 40 Hz multi-sensory (auditory and visual) stimulation is able to reduce the amyloid load in non-demented amyloid-positive individuals.
As secondary objectives, the investigators will assess whether such intervention is able to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training | Experimental | 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks). |
|
| Cognitive training only | Active Comparator | Cognitive training only (1 hour per day, per 5 days/week, for a total of 8 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training | Other | 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in amyloid load | Changes in amyloid load assessed by longitudinal amyloid-PET | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain electrical activity | Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG | 8 weeks |
| Changes in Alzheimer's blood-based biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
history of epilepsy;
clinically relevant visual or auditory diseases/deficits;
clinical diagnosis of dementia;
contraindication to amyloid-PET;
inability to undergo the procedures of the study, e.g. severe behavioral disturbances;
severe diseases:
the participation to a clinical trial involving potential Alzheimer's disease modifying therapies;
documented pregnancy or intention to become pregnant during the course of the study or breast feeding.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Cognitive training | Other | Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks) |
|
Changes in Alzheimer's blood-based biomarkers (e.g. plasma Aβ42/Aβ40 ratio, Aβ42, Aβ40, p-tau, and neurofilament light) assessed by longitudinal blood sample collection
| 8 weeks |
| Changes in cognition | Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment | 8 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |