CLearing Alzheimer's Disease Molecular Pathology Without Medications

Alzheimer Disease Clinical Trial

— CLAMP  

Official title:

CLearing Alzheimer's Disease Molecular Pathology Without Medications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04913454
• Other study ID #: 2021-00989
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyloid Plaque
• Amyloidosis
• Plaque, Amyloid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in amyloid load	Changes in amyloid load assessed by longitudinal amyloid-PET	8 weeks
Secondary	Changes in brain electrical activity	Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG	8 weeks
Secondary	Changes in Alzheimer's blood-based biomarkers	Changes in Alzheimer's blood-based biomarkers (e.g. plasma Aß42/Aß40 ratio, Aß42, Aß40, p-tau, and neurofilament light) assessed by longitudinal blood sample collection	8 weeks
Secondary	Changes in cognition	Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment	8 weeks