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Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining)

Primary Purpose

Mild Cognitive Impairment, Memory Disorders, Memory Impairment

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Training
Crossword Puzzles
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring memory, computerized training, cognition, MRI, mci, memory problems, memory complaints

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females 55 to 95 years of age (inclusive) at the time of informed consent.
  2. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
  3. Meets criteria for cognitive impairment (CI) defined as scores > 1 below standardized norms on memory function as identified by the Wechsler Memory Scale (WMS) III Logical Memory immediate or delayed recall score.
  4. Folstein Mini Mental State (MMSE) score ≥ 23 out of 30.
  5. A family member or other individual who is in contact with the patient and consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other.
  6. Access to a home desktop or laptop computer at acceptable internet speed for the study duration.

Exclusion Criteria:

  1. Diagnosis of dementia of any type.
  2. Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria).
  3. Active suicidal ideation or plan.
  4. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria).
  5. Clinical stroke with residual neurological deficits. While we will not exclude patients with cerebrovascular disease, we will not include patients who have had a stroke with residual clinical deficits because it is not clear that this type of patient is similar to the MCI (Mild Cognitive Impairment) patient generally, and clear-cut neurological impairment, e.g., hemiplegia/hemiparesis or speech impairment, may compromise the patient's ability to do the CCT or active control procedures and to complete the neuropsychological test battery.
  6. Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergics. Other patients receive medications that may be associated with cognitive impairment but are rarely considered the likely etiology, e.g., theophylline, nifedipine, beta blockers; they will not be excluded. Patients receiving other psychotropic medications not expected to have a material impact on cognition, e.g., SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-norepinephrine reuptake inhibitors) will be eligible.
  7. Presence of any of the following disorders: a) Central Nervous System infection, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis; g) Mental retardation.
  8. Acute, severe unstable medical illness. For cancer, acutely ill patients (including those with metastases) will be excluded, but past history of successfully treated cancer will not result in exclusion.
  9. Contraindication to MRI scan: pacemaker, metal implants following surgery, any other contraindication to MRI. Eligibility for the MRI scan is a requirement for the study.
  10. UPSIT (University of Pennsylvania Smell Identification Test) exclusions: current smoker > 1 pack daily, current upper respiratory infection (retested as soon as the infection clears). UPSIT scores are reduced in schizophrenia, Parkinson's disease and Parkinson's related conditions; these disorders are exclusion criteria for this study. Patients with UPSIT exclusions, e.g., current heavy smoker (less than 3% of older adults in our experience), will not receive the UPSIT but will continue to participate in all other aspects of the study.
  11. Patients lacking English-speaking ability as determined by self-report and clinical evaluation.
  12. Regular online brain training or regular crossword puzzle user, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening. Eligible participants who join the trial are instructed not to do these procedures on their own during the trial, i.e., independent of the study.
  13. Participation in another intervention trial for cognitive impairment.

Sites / Locations

  • New York State Psychiatric Institute
  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Training Group 1

Training Group 2

Arm Description

Computerized Cognitive Training

Crossword puzzles

Outcomes

Primary Outcome Measures

Change overtime in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation.

Secondary Outcome Measures

Neuropsychological Testing Composite Score
Neuropsychological Testing Composite Score is a compiled score of all neuropsychological tests administered in the protocol, i.e. Auditory Verbal Learning Test, Block Design, Verbal Fluency, Visual Reproduction, Boston Naming Task, Trails A and B
Change overtime in Pfeffer Functional Activities Questionnaire (FAQ)
FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning.
UPSA
It is a performance-based measure of functional abilities that includes measures of simulated real-world activities, for example, planning a trip to the beach, remembering documents to bring to a medical appointment, and dialing a phone number.
Change overtime in the Neurocognitive Performance Test
NCPT is a set of assessments that test your skills using tasks independent of the Lumosity games. This test is completed online using your Lumosity login.

Full Information

First Posted
June 22, 2017
Last Updated
October 3, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
Duke University, Queens College, The City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT03205709
Brief Title
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
Acronym
CogTraining
Official Title
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Duke University, Queens College, The City University of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate if systematic cognitive training can improve cognitive performance in participants (55 and older) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. Although there is no distribution of medication for this study, participants are required to have an at-home computer.
Detailed Description
In this clinical trial, investigators will evaluate if systematic cognitive training can improve cognitive performance in participants with memory loss. This study is for those who have demonstrated difficulty with memory. It will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. In this study, participants will be randomly assigned to Training Group 1 or 2; therefore, one will have a 50% chance of being assigned to CCT, and a 50% chance of being assigned to Crossword Puzzle Training (CPT). During the 18- month period, participants will be asked to come to the Memory Disorders Clinic at the New York State Psychiatric Institute (NYSPI) for a screening evaluation, and if eligible, will return for five follow-up visits at Weeks 12, 32, 52, and 78.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Memory Disorders, Memory Impairment, Cognitive Impairment, Cognitive Disorder, Cognitive Decline
Keywords
memory, computerized training, cognition, MRI, mci, memory problems, memory complaints

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group 1
Arm Type
Active Comparator
Arm Description
Computerized Cognitive Training
Arm Title
Training Group 2
Arm Type
Placebo Comparator
Arm Description
Crossword puzzles
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Training
Intervention Description
Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
Intervention Type
Other
Intervention Name(s)
Crossword Puzzles
Intervention Description
These are intended to mimic crossword puzzles in newspapers.
Primary Outcome Measure Information:
Title
Change overtime in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Description
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Secondary Outcome Measure Information:
Title
Neuropsychological Testing Composite Score
Description
Neuropsychological Testing Composite Score is a compiled score of all neuropsychological tests administered in the protocol, i.e. Auditory Verbal Learning Test, Block Design, Verbal Fluency, Visual Reproduction, Boston Naming Task, Trails A and B
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
Change overtime in Pfeffer Functional Activities Questionnaire (FAQ)
Description
FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning.
Time Frame
[Time Frame: Screen, Weeks 12, 20, 32 52, 78]
Title
UPSA
Description
It is a performance-based measure of functional abilities that includes measures of simulated real-world activities, for example, planning a trip to the beach, remembering documents to bring to a medical appointment, and dialing a phone number.
Time Frame
[Time Frame: Baseline, Weeks 32, 78]
Title
Change overtime in the Neurocognitive Performance Test
Description
NCPT is a set of assessments that test your skills using tasks independent of the Lumosity games. This test is completed online using your Lumosity login.
Time Frame
[Time Frame: Baseline, Weeks 12, 78]
Other Pre-specified Outcome Measures:
Title
Geriatric Depression Scale
Description
Used to assess depression
Time Frame
[Time Frame: Screen, Weeks 12, 32, 52, 78)
Title
MMSE (Mini Mental Status Exam)
Description
A 30-point questionnaire that is widely used in clinical research to measure cognitive impairment.
Time Frame
[Time Frame: Screen, Weeks 12, 32 52, 78]
Title
WMS-III Logical Memory I & II
Description
Used to measure logical memory function in an individual. Participant is read stories, and asked to remember the story's details at two different time points.
Time Frame
[Time Frame: Screen]
Title
Block Design
Description
Block Design is primarily a measure of visual-spatial and organizational processing abilities, as well as nonverbal problem-solving skills.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
Verbal Fluency
Description
Assesses phonemic fluency by requesting the participant to orally produce as many words as possible that begin with certain letters within a 60-second time period.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
Boston Naming Task
Description
It is a confrontational word retrieval task for 60-items.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
Trails A and B
Description
Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
User engagement scale
Description
This measures (version adapted for computer games) multiple aspects of engagement, usability and satisfaction on a 5-point Likert scale and comprises both negative ("I felt annoyed when on this site", "the game was confusing") and positive ("I really had fun", "It was really worthwhile") items.
Time Frame
[Time Frame: Week 12, 78]
Title
UPSIT (University of Pennsylvania Smell Identification Test)
Description
This assesses olfactory identification deficits. Participants will be asked to scratch smells in testing booklets, and choose the selection that best corresponds to the odor that is being emitted.
Time Frame
[Time Frame: Baseline, Week 78)
Title
Cognitive Reserve Index
Description
A brief questionnaire assessing for cognitive reserve.
Time Frame
[Time Frame: Screen]
Title
Visual Reproduction Test
Description
A test used to assess visual memory.
Time Frame
[Time Frame: Baseline, Weeks 12, 52, 78]
Title
MRI Hippocampal Volume
Description
Mean right and left hippocampal volume.
Time Frame
[Time Frame: Baseline, Week 78]
Title
MRI Cortical Thickness
Description
Mean right and left cortical thickness.
Time Frame
Time Frame: Baseline, Week 78]
Title
fMRI Default Mode Network (DMN)
Description
Functional MRI default mode network.
Time Frame
[Time Frame: Baseline, Week 78]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females 55 to 95 years of age (inclusive) at the time of informed consent. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language. Meets criteria for cognitive impairment (CI) defined as scores > 1 below standardized norms on memory function as identified by the Wechsler Memory Scale (WMS) III Logical Memory immediate or delayed recall score. Folstein Mini Mental State (MMSE) score ≥ 23 out of 30. A family member or other individual who is in contact with the patient and consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other. Access to a home desktop or laptop computer at acceptable internet speed for the study duration. Exclusion Criteria: Diagnosis of dementia of any type. Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria). Active suicidal ideation or plan. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria). Clinical stroke with residual neurological deficits. While we will not exclude patients with cerebrovascular disease, we will not include patients who have had a stroke with residual clinical deficits because it is not clear that this type of patient is similar to the MCI (Mild Cognitive Impairment) patient generally, and clear-cut neurological impairment, e.g., hemiplegia/hemiparesis or speech impairment, may compromise the patient's ability to do the CCT or active control procedures and to complete the neuropsychological test battery. Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergics. Other patients receive medications that may be associated with cognitive impairment but are rarely considered the likely etiology, e.g., theophylline, nifedipine, beta blockers; they will not be excluded. Patients receiving other psychotropic medications not expected to have a material impact on cognition, e.g., SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-norepinephrine reuptake inhibitors) will be eligible. Presence of any of the following disorders: a) Central Nervous System infection, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis; g) Mental retardation. Acute, severe unstable medical illness. For cancer, acutely ill patients (including those with metastases) will be excluded, but past history of successfully treated cancer will not result in exclusion. Contraindication to MRI scan: pacemaker, metal implants following surgery, any other contraindication to MRI. Eligibility for the MRI scan is a requirement for the study. UPSIT (University of Pennsylvania Smell Identification Test) exclusions: current smoker > 1 pack daily, current upper respiratory infection (retested as soon as the infection clears). UPSIT scores are reduced in schizophrenia, Parkinson's disease and Parkinson's related conditions; these disorders are exclusion criteria for this study. Patients with UPSIT exclusions, e.g., current heavy smoker (less than 3% of older adults in our experience), will not receive the UPSIT but will continue to participate in all other aspects of the study. Patients lacking English-speaking ability as determined by self-report and clinical evaluation. Regular online brain training or regular crossword puzzle user, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening. Eligible participants who join the trial are instructed not to do these procedures on their own during the trial, i.e., independent of the study. Participation in another intervention trial for cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davangere P Devanand, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murali Doraiswamy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel Sneed, PhD
Organizational Affiliation
Queens College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31471436
Citation
D'Antonio J, Simon-Pearson L, Goldberg T, Sneed JR, Rushia S, Kerner N, Andrews H, Hellegers C, Tolbert S, Perea E, Petrella J, Doraiswamy PM, Devanand D. Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. BMJ Open. 2019 Aug 30;9(8):e028536. doi: 10.1136/bmjopen-2018-028536. Erratum In: BMJ Open. 2019 Sep 11;9(9):e028536corr1.
Results Reference
derived

Learn more about this trial

Cognitive Training and Neuroplasticity in Mild Cognitive Impairment

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