Cognitive Training and Neuroplasticity in Mild Cognitive Impairment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2021-12-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Memory Disorders Memory Impairment Cognitive Impairment Cognitive Disorder Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Training Group 1

Computerized Cognitive Training

Group Type ACTIVE_COMPARATOR

Computerized Cognitive Training

Intervention Type OTHER

Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.

Training Group 2

Crossword puzzles

Group Type PLACEBO_COMPARATOR

Crossword Puzzles

Intervention Type OTHER

These are intended to mimic crossword puzzles in newspapers.

Interventions

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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.

Intervention Type OTHER

Crossword Puzzles

These are intended to mimic crossword puzzles in newspapers.

Intervention Type OTHER

Eligibility Criteria

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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 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 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 Re-uptake Inhibitors) and SNRIs (Serotonin-norepinephrine re-uptake 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.
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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No