Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease

NCT05077826 | Completed DMC FDA Device

• 1 other identifier: 21-203
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Dementia; Memory; Transcranial direct current stimulation (tDCS); Magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Learning Task Performance

  Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.

  Within one hour after treatment

Study Arms (2)

Full Current tES

EXPERIMENTAL

TES delivered with the anode over the right temple and cathode on the left arm, at an intensity of up to 4 milliamps, delivered for up to 40 minutes.

Device: North Coast Medical Activadose II

Partial Current tES

PLACEBO COMPARATOR

TES delivered with the anode over the right temple and cathode on the left arm, at an intensity of 0.1 milliamp, delivered for up to 40 minutes.

Device: North Coast Medical Activadose II

Interventions

North Coast Medical Activadose II DEVICE

tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

Full Current tES; Partial Current tES

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, as verified via photo identification with date of birth.
• Should be right-handed and learned English by seven years old.
• Generally healthy
• years of age, as verified via photo identification with date of birth.
• Should be right-handed and learned English by seven years old.
• Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
• Has a caregiver that can assist with taking health history.

You may not qualify if:

• Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS \>5 if uncertain.
• Current excessive drug, alcohol or nicotine use defined by participant self-report.
• History of epilepsy, migraines, severe stroke, or traumatic brain injury.
• Taking medications with significant psychotropic effects.
• Severe sensory impairment.
• Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
• Severe subjective cognitive concerns.
• Requires a helper animal.
• Has sufficient prior experience with neurostimulation that might unblind or alter the results.
• Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation or be an MRI contraindication, or has any other MRI contraindication.
• Has sensitivity to components of tES electrodes being used (typically nickel or latex).
• Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, recent or unusual (for them) loss of taste or smell, congestion or runny nose, nausea or diarrhea.
• Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
• Current excessive drug, alcohol or nicotine use.
• Significant history of epilepsy, stroke, or traumatic brain injury.

Sponsors & Collaborators

• The Mind Research Network: lead

Study Sites (1)

Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Vincent Clark, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 14, 2021
• Study Start: October 7, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)