Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining)

• ClinicalTrials.gov Identifier: NCT03205709
• Recruitment Status: Recruiting
• First Posted: July 2, 2017
• Last Update Posted: December 17, 2019
• Sponsor: New York State Psychiatric Institute
• Collaborators: Duke University; Queens College, The City University of New York
• Information provided by (Responsible Party): Davangere P. Devanand, New York State Psychiatric Institute

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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment; Memory Disorders; Memory Impairment; Cognitive Impairment; Cognitive Disorder; Cognitive Decline	Other: Computerized Cognitive Training; Other: Crossword Puzzles	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
• Actual Study Start Date: November 29, 2017
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Training Group 1; Computerized Cognitive Training	Other: 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	Other: Crossword Puzzles; These are intended to mimic crossword puzzles in newspapers.

Outcome Measures

Primary Outcome Measures :

1. Change overtime in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78] ]
   The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation.
2. UPSA [ Time Frame: [Time Frame: Baseline, Weeks 32, 78] ]
   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.

Secondary Outcome Measures :

1. Neuropsychological Testing Composite Score [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 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
2. Change overtime in Pfeffer Functional Activities Questionnaire (FAQ) [ Time Frame: [Time Frame: Screen, Weeks 12, 20, 32 52, 78] ]
   FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning.

Other Outcome Measures:

1. Geriatric Depression Scale [ Time Frame: [Time Frame: Screen, Weeks 12, 32, 52, 78) ]
   Used to assess depression
2. 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.
3. 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.
4. 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.
5. 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.
6. Boston Naming Task [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78] ]
   It is a confrontational word retrieval task for 60-items.
7. 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.
8. 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.
9. 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.
10. Cognitive Reserve Index [ Time Frame: [Time Frame: Screen] ]
    A brief questionnaire assessing for cognitive reserve.
11. Change overtime in the Neurocognitive Performance Test [ Time Frame: [Time Frame: Baseline, Weeks 12, 78] ]
    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.
12. Visual Reproduction Test [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78] ]
    A test used to assess visual memory.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Jessica L D'Antonio, BA; 646-774-8674; jessica.dantonio@nyspi.columbia.edu

Contact: Laura Simon-Pearson, BA; 646-774-8671; laura.simonpearson@nyspi.columbia.edu

Locations

United States, New York

New York State Psychiatric Institute; Recruiting

New York, New York, United States, 10032

Contact: Jessica L D'Antonio, B.A 646-774-8674 jessica.dantonio@nyspi.columbia.edu

Contact: Laura Simon-Pearson, B.A 646-774-8671 laura.simonpearson@nyspi.columbia.edu

Principal Investigator: Davangere Devanand, M.D.

Sub-Investigator: Terry Goldberg, PhD

Sub-Investigator: Nancy Kerner, M.D.

United States, North Carolina

Duke University; Recruiting

Durham, North Carolina, United States, 27710

Contact: Caroline Hellegers, MA 919-681-3986 caroline.hellegers@duke.edu

Principal Investigator: Murali Doraiswamy, MD

Sponsors and Collaborators

New York State Psychiatric Institute

Duke University

Queens College, The City University of New York

Investigators

• Principal Investigator: Davangere P Devanand, MD; Columbia University
• Principal Investigator: Murali Doraiswamy, MD; Duke University
• Principal Investigator: Joel Sneed, PhD; Queens College

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Davangere P. Devanand, Professor of Clinical Psychiatry and Neurology, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03205709
• Other Study ID Numbers: 7395
• First Posted: July 2, 2017
• Last Update Posted: December 17, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Davangere P. Devanand, New York State Psychiatric Institute:

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

Additional relevant MeSH terms:

Memory Disorders; Disease; Cognitive Dysfunction; Cognition Disorders; Pathologic Processes; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms