CLearing Alzheimer's Disease Molecular Pathology Without Medications (CLAMP)

University Hospitals (UH)

Status: Unknown

Conditions: Alzheimer Disease; Amyloid Plaque; Amyloidosis

Treatments: Other: 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training; Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT04913454

2021-00989

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Experimental group

Description:

40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks).

Treatment:

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

Cognitive training only

Active Comparator group

Description:

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

Treatment:

Other: Cognitive training