Alzheimer DiseaseCLAMPNCT04913454
CLearing Alzheimer's Disease Molecular Pathology Without Medications
A study testing 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training and Cognitive training in people with Alzheimer Disease and Amyloid Plaque, run by University Hospital, Geneva.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Amyloid Plaque, Amyloidosis
- What is being tested?
- 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training and Cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 11Show fewer
- 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.
About this study
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.
Read more
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
- Being tested
- 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training, Cognitive training
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Cognitive trainingOther
Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in amyloid load
Changes in amyloid load assessed by longitudinal amyloid-PET
Measured: 8 weeks
Secondary outcomes (3)
Changes in brain electrical activity
Changes in brain electrical activity (e.g. gamma power spectral density) assessed by longitudinal EEG
Measured: 8 weeks
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
Measured: 8 weeks
Changes in cognition
Changes in cognition (using the Preclinical Alzheimer Cognitive Composite (PACC) score) assessed by longitudinal neuropsychological assessment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Altomare, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913454
- Sponsor's protocol ID
- 2021-00989
- Acronym
- CLAMP
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLearing Alzheimer's Disease Molecular Pathology Without Medications
- ClinicalTrials.gov ID
- NCT04913454
- Acronym / sponsor ID
- CLAMP / 2021-00989
- Conditions
- Alzheimer Disease, Amyloid Plaque, Amyloidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training | Experimental | Other: 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training40 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 | Active comparator | Other: Cognitive trainingCognitive training only (1 hour per day, per 5 days/week, for a total of 8 weeks). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training40 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 trainingCognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks) | Other | Cognitive training only |
Primary outcome
Changes in amyloid load
Time frame: 8 weeks
Changes in amyloid load assessed by longitudinal amyloid-PET
3 secondary outcomes
Changes in brain electrical activity
Time frame: 8 weeks
Changes in Alzheimer's blood-based biomarkers
Time frame: 8 weeks
Changes in cognition
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 40 Hz multi-sensory (auditory + visual) stimulation and cognitive training and Cognitive training in people with Alzheimer Disease and Amyloid Plaque, run by University Hospital, Geneva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in amyloid load (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.