Back to resultsCLearing Alzheimer's Disease Molecular Pathology Without Medications (CLAMP)
Primary Purpose
Alzheimer Disease, Amyloid Plaque, Amyloidosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training
Cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training
Cognitive training only
Arm Description
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 (1 hour per day, per 5 days/week, for a total of 8 weeks).
Outcomes
Primary Outcome Measures
Changes in amyloid load
Changes in amyloid load assessed by longitudinal amyloid-PET
Secondary Outcome Measures
Changes in brain electrical activity
Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG
Changes in Alzheimer's blood-based biomarkers
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
Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04913454
Brief Title
CLearing Alzheimer's Disease Molecular Pathology Without Medications
Acronym
CLAMP
Official Title
CLearing Alzheimer's Disease Molecular Pathology Without Medications
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Amyloid Plaque, Amyloidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training
Arm Type
Experimental
Arm Description
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks).
Arm Title
Cognitive training only
Arm Type
Active Comparator
Arm Description
Cognitive training only (1 hour per day, per 5 days/week, for a total of 8 weeks).
Intervention Type
Other
Intervention Name(s)
40 Hz multi-sensory (auditory + visual) stimulation and cognitive training
Intervention Description
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
Intervention Name(s)
Cognitive training
Intervention Description
Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
Primary Outcome Measure Information:
Title
Changes in amyloid load
Description
Changes in amyloid load assessed by longitudinal amyloid-PET
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in brain electrical activity
Description
Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG
Time Frame
8 weeks
Title
Changes in Alzheimer's blood-based biomarkers
Description
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
Time Frame
8 weeks
Title
Changes in cognition
Description
Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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CLearing Alzheimer's Disease Molecular Pathology Without Medications
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