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

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
North Coast Medical Activadose II
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Memory, Transcranial direct current stimulation (tDCS), Magnetic resonance imaging (MRI)

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mind Research NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Full Current tES

Partial Current tES

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
August 23, 2022
Sponsor
The Mind Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT05077826
Brief Title
Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease
Acronym
MEMORI
Official Title
Modern Energetic Methods of Response Improvement (MEMORI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mind Research Network

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment
Keywords
Dementia, Memory, Transcranial direct current stimulation (tDCS), Magnetic resonance imaging (MRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full Current tES
Arm Type
Experimental
Arm Description
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.
Arm Title
Partial Current tES
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
North Coast Medical Activadose II
Intervention Description
tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.
Primary Outcome Measure Information:
Title
Learning Task Performance
Description
Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.
Time Frame
Within one hour after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for healthy participants: 50-90 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 Inclusion criteria for participants with MCI or AD: 50-90 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. Exclusion Criteria: Exclusion criteria for healthy participants: 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. Exclusion criteria for participants with MCI or AD: 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. Taking medications with significant psychotropic effects, not related to neurodegenerative condition 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. 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. 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, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Assistant
Phone
(505) 221-6884
Email
MEMORISTUDY@MRN.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Clark, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent P Clark
Phone
505-272-4936
Email
vclark@unm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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