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

Sponsor
The Mind Research Network (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077826
Collaborator
(none)
120
1
2
6.7
17.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: North Coast Medical Activadose II
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modern Energetic Methods of Response Improvement (MEMORI)
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

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 mA, 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 mA, 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.

Outcome Measures

Primary Outcome Measures

  1. Learning Task Performance [Within one hour after treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mind Research Network Albuquerque New Mexico United States 87106

Sponsors and Collaborators

  • The Mind Research Network

Investigators

  • Principal Investigator: Vincent Clark, PhD, University of New Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Mind Research Network
ClinicalTrials.gov Identifier:
NCT05077826
Other Study ID Numbers:
  • 21-203
First Posted:
Oct 14, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by The Mind Research Network
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021