Cognitive Training and Neuroplasticity in Mild Cognitive Impairment

NCT03205709 | Completed Results DMC

• 1 other identifier: 7395
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

memory; computerized training; cognition; MRI; mci; memory problems; memory complaints

Outcome Measures

Primary Outcomes (1)

• Change 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. Value range: 0-70. A higher score indicates worse cognition.

  [Time Frame: 78 weeks]

Secondary Outcomes (3)

• Change Over Time in Neuropsychological Testing Composite Score

  [Time Frame: Week 78]

• Change Over Time in Functional Activities Questionnaire (FAQ)

  [Time Frame: week 78]

• Change Over Time in UCSD Performance-Based Skills Assessment (UPSA)

  [Time Frame: week 78]

Study Arms (2)

Training Group 1

ACTIVE COMPARATOR

Computerized Cognitive Training

Other: Computerized Cognitive Training

Training Group 2

PLACEBO COMPARATOR

Crossword puzzles

Other: Crossword Puzzles

Interventions

Computerized Cognitive Training 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 1

Crossword Puzzles OTHER

These are intended to mimic crossword puzzles in newspapers.

Training Group 2

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Duke University: collaborator
• Queens College, The City University of New York: collaborator

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Nwosu A, Qian M, Phillips J, Hellegers CA, Rushia S, Sneed J, Petrella JR, Goldberg TE, Devanand DP, Doraiswamy PM. Computerized Cognitive Training in Mild Cognitive Impairment: Findings in African Americans and Caucasians. J Prev Alzheimers Dis. 2024;11(1):149-154. doi: 10.14283/jpad.2023.80.

  PMID: 38230727 DERIVED

• Devanand DP, Goldberg TE, Qian M, Rushia SN, Sneed JR, Andrews HF, Nino I, Phillips J, Pence ST, Linares AR, Hellegers CA, Michael AM, Kerner NA, Petrella JR, Doraiswamy PM. Computerized Games versus Crosswords Training in Mild Cognitive Impairment. NEJM Evid. 2022 Dec;1(12):10.1056/evidoa2200121. doi: 10.1056/evidoa2200121. Epub 2022 Oct 27.

  PMID: 37635843 DERIVED

• 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.

  PMID: 31471436 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: D.P. Devanand, M.D.
• Organization: Columbia University Medical Center

dpd3@cumc.columbia.edu

774-8658

Study Officials

• Davangere P Devanand, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Murali Doraiswamy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Joel Sneed, PhD

  Queens College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry and Neurology

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: November 29, 2017
• Primary Completion: September 30, 2021
• Study Completion: December 27, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)