Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03205709|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : October 4, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Cognitive Training and Neuroplasticity in Mild Cognitive Impairment|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2023|
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
Other: Crossword Puzzles
These are intended to mimic crossword puzzles in newspapers.
- 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.
- 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
- 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.
- 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.
- 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.
- Geriatric Depression Scale [ Time Frame: [Time Frame: Screen, Weeks 12, 32, 52, 78) ]Used to assess depression
- 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.
- 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.
- 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.
- 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.
- Boston Naming Task [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78] ]It is a confrontational word retrieval task for 60-items.
- 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.
- 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.
- 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.
- Cognitive Reserve Index [ Time Frame: [Time Frame: Screen] ]A brief questionnaire assessing for cognitive reserve.
- Visual Reproduction Test [ Time Frame: [Time Frame: Baseline, Weeks 12, 52, 78] ]A test used to assess visual memory.
- MRI Hippocampal Volume [ Time Frame: [Time Frame: Baseline, Week 78] ]Mean right and left hippocampal volume.
- MRI Cortical Thickness [ Time Frame: Time Frame: Baseline, Week 78] ]Mean right and left cortical thickness.
- fMRI Default Mode Network (DMN) [ Time Frame: [Time Frame: Baseline, Week 78] ]Functional MRI default mode network.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205709
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Davangere P Devanand, MD||Columbia University|
|Principal Investigator:||Murali Doraiswamy, MD||Duke University|
|Principal Investigator:||Joel Sneed, PhD||Queens College|