NCT06094192

Brief Summary

The investigators will evaluate the theory that Alzheimer's disease-related memory impairment derives from the inefficient orchestration of rhythmic activity at the level of large-scale cortical networks. The results as expected to elucidate AD-related pathophysiology and set groundwork for the development of drug-free interventions for improving memory in AD and related dementias.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
25mo left

Started Dec 2023

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

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Study Timeline

Key milestones and dates

Study Progress54%
Dec 2023May 2028

First Submitted

Initial submission to the registry

October 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

October 14, 2023

Last Update Submit

September 15, 2025

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • Memory performance (active stimulation condition)

    The accuracy of task performance on memory test

    Time Frame: Memory performance data is collected during active brain stimulation and reported 1 year later

  • Memory performance (sham stimulation condition)

    The accuracy of task performance on memory test

    Time Frame: Memory performance data is collected during sham brain stimulation and reported 1 year later

Study Arms (2)

active stimulation

EXPERIMENTAL

Memory performance data is collected during active brain stimulation and reported 1 year later

Device: High definition transcranial electrical current stimulation

sham stimulation

SHAM COMPARATOR

Memory performance data is collected during sham brain stimulation and reported 1 year later

Device: High definition transcranial electrical current stimulation

Interventions

High definition transcranial electrical current stimulationDEVICE

Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.

active stimulationsham stimulation

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • All subjects. Current conditions allowed: mild depression and/or anxiety not requiring hospitalization or medications other than what are listed below; hyperlipidemia; hypercholesterolemia; hypertension; heart disease; asthma; gastroesophageal reflux disease; edema; treated hypothyroidism; systemic vascular disease (but not stroke); dermatological disorders; ophthalmologic disorders. Prior conditions excluded: stroke, traumatic brain injury, other brain or systemic disorder that, in the opinion of Dr. Budson, has produced a permanent alteration of cognition. Current medications allowed: selective serotonin reuptake inhibitors; cholinesterase inhibitors (for the patients with AD); statins; beta adrenergic blockers; bronchodilators; ace inhibitors; calcium channel blockers; angiotensin II receptor blockers; other antihypertensive agents; histamine-2 receptor antagonists; proton-pump inhibitors; diuretics; thyroid medications; aspirin; non-narcotic analgesics; antiplatelet agents; vitamins \& minerals; topical medications; eye drops.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

677 Beacon St. Room 308

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Robert M. G. Reinhart, PhD

CONTACT

(617) 353-9481rmgr@bu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 23, 2023

Study Start

December 20, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

US(1)