NCT03556280

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

May 22, 2018

Last Update Submit

August 23, 2021

Conditions

Alzheimer DiseaseCognitive ImpairmentMild Cognitive ImpairmentDementia AlzheimersDementia, MildDementia, Alzheimer TypeDementia of Alzheimer TypeDementiaCognitive Impairment, MildCognitive Decline

Keywords

DementiaAlzheimer's DiseaseCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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

    Quarterly over 6 months

Secondary Outcomes (1)

  • Amyloid PET/CT

    Quarterly over 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Will use the Active GammaSense Stimulation System.

Device: GammaSense Stimulation System (Active Settings)

Control Group

SHAM COMPARATOR

Will use the Sham GammaSense Stimulation System.

Device: GammaSense Stimulation System (Sham Settings)

Interventions

GammaSense Stimulation System (Active Settings)DEVICE

Proprietary auditory and visual sensory stimulation device.

Treatment Group
GammaSense Stimulation System (Sham Settings)DEVICE

Proprietary auditory and visual sensory stimulation device.

Control Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 55 Years old
  • MMSE 14-26
  • Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
  • Participation of a caregiver

You may not qualify if:

  • Profound hearing or visual impairment
  • Seizure Disorder
  • Use of memantine (Namenda or Namzaric)
  • Implantable devices (non-MR compatible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Brain Matters Research

Stuart, Florida, 34994, United States

Location

ActivMed Practices & Research, Inc

Methuen, Massachusetts, 01844, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Related Publications (3)

  • 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.

    PMID: 40082316DERIVED

  • Hajos 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.

    PMID: 38515445DERIVED

  • Cimenser 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.

    PMID: 34630050DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementiaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 14, 2018

Study Start

April 24, 2018

Primary Completion

August 1, 2020

Study Completion

September 1, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

US(5)