NCT04913454

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable alzheimer-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

May 25, 2021

Last Update Submit

May 28, 2021

Conditions

Alzheimer DiseaseAmyloid PlaqueAmyloidosis

Outcome Measures

Primary Outcomes (1)

  • Changes in amyloid load

    Changes in amyloid load assessed by longitudinal amyloid-PET

    8 weeks

Secondary Outcomes (3)

  • Changes in brain electrical activity

    8 weeks

  • Changes in Alzheimer's blood-based biomarkers

    8 weeks

  • Changes in cognition

    8 weeks

Study Arms (2)

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).

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

Cognitive training only

ACTIVE COMPARATOR

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

Other: Cognitive training

Interventions

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

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

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

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

Cognitive training only

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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:
  • Malignant neoplasm within 5 years,
  • Life threatening diseases,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseasePlaque, AmyloidAmyloidosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 4, 2021

Study Start

August 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

June 4, 2021

Record last verified: 2021-05