NCT05984524

Brief Summary

The study will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention for participants with mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and behavioral intervention by combining music therapy with gamma- band neurostimulation, the present project aims to find a sustainable intervention that delays the progression of AD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
14mo left

Started Jul 2022

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Jul 2022Jun 2027

Study Start

First participant enrolled

July 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

June 16, 2023

Last Update Submit

October 4, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • EEG activity

    Gamma-band EEG activity

    1 hour

Secondary Outcomes (1)

  • ADAS-Cog 14

    8 weeks

Study Arms (2)

Gamma

EXPERIMENTAL

8-week music-based intervention with gamma lights

Behavioral: Gamma-Music Based Intervention

Control

PLACEBO COMPARATOR

8-week music-based intervention with control lights

Behavioral: Gamma-Music Based Intervention

Interventions

Gamma-Music Based InterventionBEHAVIORAL

Gamma or Control lights with Music-Based Intervention for 8 week period

ControlGamma

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sham placebo control intervention
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

August 9, 2023

Study Start

July 1, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

US(1)