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

Modern Energetic Methods of Response Improvement (MEMORI)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Device: North Coast Medical Activadose II

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Assistant; Phone Number: (505) 221-6884; Email: MEMORISTUDY@MRN.ORG

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Mind Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Inclusion criteria for healthy participants:

1. 50-90 years of age, as verified via photo identification with date of birth.
2. Should be right-handed and learned English by seven years old.
3. Generally healthy

Inclusion criteria for participants with MCI or AD:

1. 50-90 years of age, as verified via photo identification with date of birth.
2. Should be right-handed and learned English by seven years old.
3. Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
4. Has a caregiver that can assist with taking health history.

Exclusion Criteria:

Exclusion criteria for healthy participants:

1. Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.
2. Current excessive drug, alcohol or nicotine use defined by participant self-report.
3. History of epilepsy, migraines, severe stroke, or traumatic brain injury.
4. Taking medications with significant psychotropic effects.
5. Severe sensory impairment.
6. 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.
7. Severe subjective cognitive concerns.
8. Requires a helper animal.
9. Has sufficient prior experience with neurostimulation that might unblind or alter the results.
10. 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.
11. Has sensitivity to components of tES electrodes being used (typically nickel or latex).
12. 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.

Exclusion criteria for participants with MCI or AD:

1. Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
2. Current excessive drug, alcohol or nicotine use.
3. Significant history of epilepsy, stroke, or traumatic brain injury.
4. Taking medications with significant psychotropic effects, not related to neurodegenerative condition
5. Severe sensory impairment
6. 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.
7. Requires a helper animal.
8. Has sufficient prior experience with neurostimulation that might unblind or alter the results.
9. Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.
10. Has sensitivity to components of tES electrodes being used (typically nickel or latex).
11. 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, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full Current tES; 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; tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.
Placebo Comparator: Partial Current tES; 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; tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Mind Research Network
• Investigators: Principal Investigator: Vincent Clark, PhD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dementia; Memory; Transcranial direct current stimulation (tDCS); Magnetic resonance imaging (MRI)
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 21-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes