Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601933
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment COGIT-2 Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment COGIT-2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGIT-2
Brief Summary:
Effective clinically meaningful treatments are lacking for patients with mild cognitive impairment MCI which is associated with increased risk of transition to dementia Cognitive training represents an important therapeutic strategy In a previous study crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy Building on these findings this study will evaluate and compare the impact of high dose crosswords 4 puzzles per week to low dose crosswords 1 puzzle per week and a health education control group on the cognition and function of participants
Detailed Description:
This study plans to enroll 240 participants with MCI 75 at Columbia University 60 at Duke 60 at University of Miami 45 at University of Washington Participants will be randomized 111 to 4 crossword puzzles per week high dose arm 1 crossword puzzle per week low dose arm or health education control arm In the crossword groups this initial intensive 12-week phase will be followed by booster sessions that will each comprise 30-minute sessions 1 or 4 sessions depending on assignment completed over 1 week and occur at weeks 20 32 42 52 64 and 78 In-person assessments will occur at 0 12 32 52 78 weeks During weeks 0 12 32 52 and 78 participants in the 4week crosswords group will complete three sessions at home and the fourth in clinic and participants in the 1week group will complete one session in the clinic and none at home During weeks 20 42 and 64 participants will complete all sessions at home The health education group will receive in-person sessions and assessments at weeks 0 12 32 52 and 78 weeks each for 30 min same time frame as the crossword groups and phone calls will be made each for 30 min at weeks 20 42 and 64 to match the crossword groups each 30 min Unique features of the design Evaluation of home-based crossword puzzles as the primary intervention Comparison of two dose conditions to a comparison group Health education comparison group with readings to mimic placebo in clinical trials Stratification of random assignment by site age and early MCIlate MCI Evaluation of MRI atrophy indices and plasma biomarkers of neurodegeneration Neurofilament Light Nfl and Alzheimer Disease pathology ptau-217
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None