Alzheimer Disease, Early OnsetNCT03661034
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
A study testing GammaSense Stimulation System (non-invasive, non-significant risk) in people with Alzheimer Disease, Early Onset and Alzheimer Disease, run by Cognito Therapeutics, Inc. at 1 site in United States.
Trial summary
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Dementia
- What is being tested?
- GammaSense Stimulation System (non-invasive, non-significant risk)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 1 Mar 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 50 Years Old
- MMSE 24 - 30
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver / care partner
- Amyloid Positive PET Scan
Who cannot join
- Profound hearing or visual impairment
- Seizure Disorder
- Use of memantine (Namenda or Namzaric)
- Implantable devices (non-MR compatible)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Center for Memory
Newton, Massachusetts, 02459
About this study
Official title: Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
Read the detailed description
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Dementia, Mild Cognitive Impairment, Memory Disorders, Memory Loss
- Being tested
- GammaSense Stimulation System (non-invasive, non-significant risk)
- Keywords
- Dementia, Alzheimer's Disease, Memory Loss
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Memory Disorders, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaSense Stimulation System (non-invasive, non-significant risk)Device
Also called FG-0003
Non-invasive, non-significant risk audio-visual sensory stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Arm A | Experimental | Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk) Receives: Device: GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 1, Arm B | Experimental | Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk) Receives: Device: GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 2, Arm C | Experimental | Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) Receives: Device: GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 2, Arm D | Experimental | Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) Receives: Device: GammaSense Stimulation System (non-invasive, non-significant risk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amyloid Positron Emission Tomography (PET) Scan
Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions
Measured: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)
Adverse Events
Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).
Measured: Over 12 months
Secondary outcomes (1)
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption.
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start31 May 2018
- Primary completion1 May 2021
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- 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
- Model description
- Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognito Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evan R Hempel, Study chair, Cognito Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661034
- Sponsor's protocol ID
- CA-0004
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
- ClinicalTrials.gov ID
- NCT03661034
- Acronym / sponsor ID
- CA-0004
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Dementia, Mild Cognitive Impairment, Memory Disorders, Memory Loss
- Keywords
- Dementia, Alzheimer's Disease, Memory Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cognito Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 7 Sep 2018 (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.
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
Detailed description
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Arm A | Experimental | Device: GammaSense Stimulation System (non-invasive, non-significant risk)Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 1, Arm B | Experimental | Device: GammaSense Stimulation System (non-invasive, non-significant risk)Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 2, Arm C | Experimental | Device: GammaSense Stimulation System (non-invasive, non-significant risk)Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) |
| Cohort 2, Arm D | Experimental | Device: GammaSense Stimulation System (non-invasive, non-significant risk)Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 50 Years Old
- MMSE 24 - 30
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver / care partner
- Amyloid Positive PET Scan
Key exclusion criteria (4 listed)
- Profound hearing or visual impairment
- Seizure Disorder
- Use of memantine (Namenda or Namzaric)
- Implantable devices (non-MR compatible)
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 |
|---|---|---|
| GammaSense Stimulation System (non-invasive, non-significant risk)Also: FG-0003Non-invasive, non-significant risk audio-visual sensory stimulation device | Device | Cohort 1, Arm A, Cohort 1, Arm B, Cohort 2, Arm C, Cohort 2, Arm D |
Primary outcome
Change in Amyloid Positron Emission Tomography (PET) Scan
Time frame: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)
Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions
Adverse Events
Time frame: Over 12 months
Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).
1 secondary outcome
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Time frame: Baseline, 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Evan R Hempel study chair
Cognito Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaSense Stimulation System (non-invasive, non-significant risk) in people with Alzheimer Disease, Early Onset and Alzheimer Disease, run by Cognito Therapeutics, Inc. at 1 site in United States.
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 5 inclusion and 4 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Amyloid Positron Emission Tomography (PET) Scan (time frame: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)). The study lists 2 primary outcomes in all. 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 24 Aug 2021.