CLearing Alzheimer's Disease Molecular Pathology Without Medications

NCT ID: NCT04913454

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-07-31

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.

Conditions

Alzheimer Disease; Amyloid Plaque; Amyloidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

40 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).

Group Type: EXPERIMENTAL

40 Hz multi-sensory (auditory + visual) stimulation and cognitive training

Intervention Type: OTHER

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

Cognitive training only (1 hour per day, per 5 days/week, for a total of 8 weeks).

Group Type: ACTIVE_COMPARATOR

Cognitive training

Intervention Type: OTHER

Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)

Interventions

40 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)

Intervention Type: OTHER

Cognitive training

Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Daniele Altomare

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2021-00989

Identifier Type: -

Identifier Source: org_study_id