Alzheimer DiseaseOvertureNCT03556280
Multi-Center Study of Sensory Stimulation to Improve Brain Function
A study testing GammaSense Stimulation System (Active Settings) in people with Alzheimer Disease and Cognitive Impairment, run by Cognito Therapeutics, Inc. at 5 sites in United States.
Trial summary
The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- GammaSense Stimulation System (Active Settings)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Apr 2018to Sep 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 55 Years old
- MMSE 14-26
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver
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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Brain Matters Research
Delray Beach, Florida, 33445
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844
Boston Center for Memory
Newton, Massachusetts, 02459
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
Brain Matters Research
Stuart, Florida, 34994
About this study
Official title: Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.
Read the detailed description
The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.
- Conditions
- Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mild, Dementia, Alzheimer Type
- Being tested
- GammaSense Stimulation System (Active Settings), GammaSense Stimulation System (Sham Settings)
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, 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 (Active Settings)Device
Proprietary auditory and visual sensory stimulation device.
GammaSense Stimulation System (Sham Settings)Device
Proprietary auditory and visual sensory stimulation device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Will use the Active GammaSense Stimulation System. Receives: Device: GammaSense Stimulation System (Active Settings) |
| Control Group | Sham comparator | Will use the Sham GammaSense Stimulation System. Receives: Device: GammaSense Stimulation System (Sham Settings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment
Measured: Quarterly over 6 months
Secondary outcomes (1)
Amyloid PET/CT
Measured: Quarterly over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start24 Apr 2018
- Primary completion1 Aug 2020
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognito Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556280
- Sponsor's protocol ID
- CA-0005
- Acronym
- Overture
- Status last verified
- Aug 2021
- First submitted
- 22 May 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Carbonell F, Zijdenbos AP, Hempel E, Hajos M, Bedell BJ. A novel method for harmonization of PET image spatial resolution without phantoms. EJNMMI Phys. 2025 Mar 14;12(1):23. doi: 10.1186/s40658-025-00740-9.
PubMed 40082316Hajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024.
PubMed 38515445Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
PubMed 34630050
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 Sensory Stimulation to Improve Brain Function (Overture Study)
- ClinicalTrials.gov ID
- NCT03556280
- Acronym / sponsor ID
- Overture / CA-0005
- Conditions
- Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mild, Dementia, Alzheimer Type
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cognito Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Jun 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 Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.
Detailed description
The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: GammaSense Stimulation System (Active Settings)Will use the Active GammaSense Stimulation System. |
| Control Group | Sham comparator | Device: GammaSense Stimulation System (Sham Settings)Will use the Sham GammaSense Stimulation System. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 55 Years old
- MMSE 14-26
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver
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 (Active Settings)Proprietary auditory and visual sensory stimulation device. | Device | Treatment Group |
| GammaSense Stimulation System (Sham Settings)Proprietary auditory and visual sensory stimulation device. | Device | Control Group |
Primary outcome
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Time frame: Quarterly over 6 months
A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment
1 secondary outcome
Amyloid PET/CT
Time frame: Quarterly over 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 40082316Carbonell F, Zijdenbos AP, Hempel E, Hajos M, Bedell BJ. A novel method for harmonization of PET image spatial resolution without phantoms. EJNMMI Phys. 2025 Mar 14;12(1):23. doi: 10.1186/s40658-025-00740-9.
- Derived from this study: PubMed 38515445Hajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024.
- Derived from this study: PubMed 34630050Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
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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.
5 sites 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 (Active Settings) in people with Alzheimer Disease and Cognitive Impairment, run by Cognito Therapeutics, Inc. at 5 sites 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 4 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: under way, not looking for participants, 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 5 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (time frame: Quarterly over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556280, which also lists 3 linked publications.
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.