Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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 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 Re-uptake Inhibitors) and SNRIs (Serotonin-norepinephrine re-uptake 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Training Group 1
Computerized Cognitive Training
|
Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
|
|
Placebo Comparator: Training Group 2
Crossword puzzles
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These are intended to mimic crossword puzzles in newspapers.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Time Frame: [Time Frame: 78 weeks]
|
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation.
Value range: 0-70.
A higher score indicates worse cognition.
|
[Time Frame: 78 weeks]
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change Over Time in Neuropsychological Testing Composite Score
Time Frame: [Time Frame: Week 78]
|
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. The composite neuropsychological test battery is derived by computing the baseline z-score for each individual test and then averaging the resulting z scores. The range will be -5 to +5. z score of 0 represents the sample mean and higher z score indicates better performance. |
[Time Frame: Week 78]
|
|
Change Over Time in Functional Activities Questionnaire (FAQ)
Time Frame: [Time Frame: week 78]
|
FAQ: Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances.
The score ranges from 0-30.
A higher score indicates a greater level of impairment in the instrumental activities of daily living.
|
[Time Frame: week 78]
|
|
Change Over Time in UCSD Performance-Based Skills Assessment (UPSA)
Time Frame: [Time Frame: week 78]
|
UPSA: UCSD Performance-Based Skills Assessment. The UPSA 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. A higher score indicates greater cognitive function. For the UPSA the z score at baseline is computed (based on the mean and SD of the raw scores). The expected range is -5 to +5 with z score of 0 representing the sample mean and higher z score indicating better performance. |
[Time Frame: week 78]
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatric Depression Scale
Time Frame: [Time Frame: Screen, Weeks 12, 32, 52, 78)
|
Used to assess depression
|
[Time Frame: Screen, Weeks 12, 32, 52, 78)
|
|
MMSE (Mini Mental Status Exam)
Time Frame: [Time Frame: Screen, Weeks 12, 32 52, 78]
|
A 30-point questionnaire that is widely used in clinical research to measure cognitive impairment.
|
[Time Frame: Screen, Weeks 12, 32 52, 78]
|
|
WMS-III Logical Memory I & II
Time Frame: [Time Frame: Screen]
|
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: Screen]
|
|
Block Design
Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78]
|
Block Design is primarily a measure of visual-spatial and organizational processing abilities, as well as nonverbal problem-solving skills.
|
[Time Frame: Baseline, Weeks 12, 52, 78]
|
|
Verbal Fluency
Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78]
|
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.
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[Time Frame: Baseline, Weeks 12, 52, 78]
|
|
Boston Naming Task
Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78]
|
It is a confrontational word retrieval task for 60-items.
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[Time Frame: Baseline, Weeks 12, 52, 78]
|
|
Trails A and B
Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78]
|
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: Baseline, Weeks 12, 52, 78]
|
|
User engagement scale
Time Frame: [Time Frame: Week 12, 78]
|
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: Week 12, 78]
|
|
UPSIT (University of Pennsylvania Smell Identification Test)
Time Frame: [Time Frame: Baseline, Week 78)
|
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: Baseline, Week 78)
|
|
Cognitive Reserve Index
Time Frame: [Time Frame: Screen]
|
A brief questionnaire assessing for cognitive reserve.
|
[Time Frame: Screen]
|
|
Visual Reproduction Test
Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78]
|
A test used to assess visual memory.
|
[Time Frame: Baseline, Weeks 12, 52, 78]
|
|
MRI Hippocampal Volume
Time Frame: [Time Frame: Baseline, Week 78]
|
Mean right and left hippocampal volume.
|
[Time Frame: Baseline, Week 78]
|
|
MRI Cortical Thickness
Time Frame: Time Frame: Baseline, Week 78]
|
Mean right and left cortical thickness.
|
Time Frame: Baseline, Week 78]
|
|
fMRI Default Mode Network (DMN)
Time Frame: [Time Frame: Baseline, Week 78]
|
Functional MRI default mode network.
|
[Time Frame: Baseline, Week 78]
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Davangere P Devanand, MD, Columbia University
- Principal Investigator: Murali Doraiswamy, MD, Duke University
- Principal Investigator: Joel Sneed, PhD, Queens College
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 7395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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