Improving Memory in Alzheimer's Disease With Noninvasive Brain Stimulation

NCT ID: NCT06094192

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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The investigators hypothesize that AD-related memory impairments emerge from large-scale functional dysconnectivity, and by stimulating the brain noninvasively with extremely weak levels of electrical current, the investigators may be able to re-synchronize connectivity and stabilize or improve memory and cognitive function, measured behaviorally. The experimental intervention involves the application of low-intensity, high-definition, transcranial electrical current stimulation while subjects perform a variety of computer-based tasks that probe memory and cognitive function.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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active stimulation

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

Group Type EXPERIMENTAL

High definition transcranial electrical current stimulation

Intervention Type DEVICE

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

sham stimulation

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

Group Type SHAM_COMPARATOR

High definition transcranial electrical current stimulation

Intervention Type DEVICE

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

Interventions

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High definition transcranial electrical current stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Robert Reinhart

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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677 Beacon St. Room 308

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert M. G. Reinhart, PhD

Role: CONTACT

(617) 353-9481

Facility Contacts

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Robert Reinhart, PhD

Role: primary

617-353-9481

Other Identifiers

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4555_2

Identifier Type: -

Identifier Source: org_study_id

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