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| Name | Class |
|---|---|
| Duke University | OTHER |
| Queens College, The City University of New York | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Group 1 | Active Comparator | Computerized Cognitive Training |
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| Training Group 2 | Placebo Comparator | Crossword puzzles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| Change Over Time in 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. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davangere P Devanand, MD | Columbia University | Principal Investigator |
| Murali Doraiswamy, MD | Duke University | Principal Investigator |
| Joel Sneed, PhD | Queens College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38230727 | Derived | 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. | |
| 37635843 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Training Group 1 | Computerized Cognitive Training 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. |
| FG001 | Training Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2023 | Apr 23, 2024 |
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| Crossword Puzzles | Other | These are intended to mimic crossword puzzles in newspapers. |
|
| [Time Frame: Week 78] |
| Change Over Time in Functional Activities Questionnaire (FAQ) | 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) | 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] |
| Durham |
| North Carolina |
| 27710 |
| United States |
| 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. |
| 31471436 | 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. |
Crossword puzzles Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers. |
| COMPLETED |
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| NOT COMPLETED |
|
107 participants with MCI
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| ID | Title | Description |
|---|---|---|
| BG000 | Training Group 1 | Computerized Cognitive Training 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. |
| BG001 | Training Group 2 | Crossword Puzzles Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| MMSE total score | MMSE: Mini Mental State Examination is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30 and the minimum is 0 points. A higher score represents better cognitive function. | Mean | Standard Deviation | score |
| ||||||||||||||||
| ADAS-Cog total score | ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale. 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. | Mean | Standard Deviation | score |
| ||||||||||||||||
| Neuropsychological composite z-score | Neuropsychological Testing Composite Score is a composite 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. As per standard z-score calculations, the z-score has a mean value of 0 and a SD of 1. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| UPSA total score | UPSA: UCSD Performance-Based Skills Assessment, range 0-100, higher scores indicate better cognitive function. This is a role-play test designed to evaluate a person's functional capacity in the communication and finance areas of basic living skills. | Mean | Standard Deviation | score |
| ||||||||||||||||
| FAQ total score | 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. | Mean | Standard Deviation | score |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome. | Posted | Least Squares Mean | Standard Error | score | [Time Frame: 78 weeks] |
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| Secondary | Change Over Time in 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. 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. | Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome. | Posted | Least Squares Mean | Standard Error | score | [Time Frame: Week 78] |
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| |||||||||||||||||||||||||||||
| Secondary | Change Over Time in Functional Activities Questionnaire (FAQ) | 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. | Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome. | Posted | Least Squares Mean | Standard Error | score | [Time Frame: week 78] |
|
| |||||||||||||||||||||||||||||
| Secondary | Change Over Time in UCSD Performance-Based Skills Assessment (UPSA) | 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. | Participants assessed at baseline and week 78, and the change over 78 weeks is the outcome. | Posted | Least Squares Mean | Standard Error | score | [Time Frame: week 78] |
|
Adverse event data was collected for each participant throughout the study participant duration of 78 weeks.
The definitions used to collect adverse event information in this study align with those from the clinicaltrials.gov definitions.
Adverse events were reported to research staff and study physicians. These adverse events were recorded, reported per the IRB guidelines, and assessed by the study DSMB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training Group 1 | Computerized Cognitive Training 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. | 0 | 51 | 12 | 51 | 19 | 51 |
| EG001 | Training Group 2 | Crossword puzzles Crossword Puzzles: These are intended to mimic crossword puzzles in newspapers. | 0 | 56 | 9 | 56 | 23 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
| ||
| Falls | General disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cardiac disorders | Cardiac disorders | Non-systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Non-systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Urinary disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Falls | General disorders | Non-systematic Assessment |
| ||
| Eye disorders | Eye disorders | Non-systematic Assessment |
| ||
| Ear, nose, throat disorders | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Skin cancer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hematological/immune disorders | Immune system disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Elective cardiac surgery | Cardiac disorders | Non-systematic Assessment |
| ||
| Urinary tract disorders | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Arthritis, musculoskeletal symptoms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| COVID-19 diagnosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| D.P. Devanand, M.D. | Columbia University Medical Center | 774-8658 | 646 | dpd3@cumc.columbia.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2022 | Apr 23, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2020 | Nov 8, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Age >70 yr with early MCI |
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| Age >70 yr with late MCI |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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