Alzheimer Disease, Amyloidosis, Amyloid Plaque
Conditions
Brief summary
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: * improve the brain electrical activity, * improve or slow down the worsening of Alzheimer's blood-based biomarkers, * improve or slow down the worsening of cognition.
Interventions
OTHER40 Hz multi-sensory (auditory + visual) stimulation and cognitive training
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
OTHERCognitive training
Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed Consent as documented by signature (Appendix Informed Consent Form), * age 40-80, * ≥5 years of education, * previous evidence of brain amyloidosis (assessed by PET, CSF, or blood-based biomarkers).
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: 1. Malignant neoplasm within 5 years, 2. Life threatening diseases, 3. Severe systemic diseases (e.g. kidney insufficiency, cardiac insufficiency, decompensated diabetes, decompensated metabolic diseases, decompensated hypothyroidism, uncontrolled autoimmune 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in amyloid load | 8 weeks | Changes in amyloid load assessed by longitudinal amyloid-PET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in brain electrical activity | 8 weeks | Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG |
| Changes in Alzheimer's blood-based biomarkers | 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 |
| Changes in cognition | 8 weeks | Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment |
Outcome results
None listed