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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Device: North Coast Medical Activadose II

• Registration Number: NCT05077826
• Lead Sponsor: The Mind Research Network

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study Start: 2021-10-07
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-14
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Current tES	North Coast Medical Activadose II	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.
Partial Current tES	North Coast Medical Activadose II	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mind Research Network; 🇺🇸 Albuquerque, New Mexico, United States