COGIT-2 (Mild Cognitive Impairment/Memory Loss)

Purpose of this Study

We are doing this study to compare 3 different kinds of brain training to find out which is most effective in improving cognitive outcomes and everyday functioning for people with mild cognitive impairment or memory loss. Participants who take part in this study will do the brain training at home.

Who Can Participate?

Eligibility

Adults ages 55-89 who:
  • Are diagnosed with mild cognitive impairment (MCI) OR do not have a diagnosis of MCI but are experiencing memory loss that is worse than what's expected from normal aging
  • Are willing and able to have 2 brain MRI scans
  • Have a study partner who can provide information about their everyday function
  • Have access to a computer or tablet
  • Do not have a diagnosis of dementia
  • Do not do crossword puzzles on a regular basis
For more information, contact the study team at caroline.hellegers@duke.edu or 919-681-3986.

Age Range

55-89

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will come in for a screening visit to make sure that you are eligible to participate. During this visit, you will have an MRI scan taken of your brain and do some cognitive testing. If you are eligible to continue, you will get a random assignment (like drawing numbers from a hat) to 1 of 3 brain training groups. You will do your brain training at home. Your group assignment might be:
  • High-frequency puzzles: If you are in this group, you will do computerized crossword puzzles 4 times per week (30 minutes per session). OR
  • Low-frequency puzzles: If you are in this group, you will do computerized crossword puzzles once per week (30 minutes per session). OR
  • Health education training: If you are in this group, you will do health education training once per week (30 minutes per session).
This study lasts for about 78 weeks (1.5 years). Your assigned brain training will last for 12 weeks. After the 12 weeks are done, we will schedule you to come in for follow-up visits at 12, 32, 52, and 78 weeks for cognitive testing. Around the times you come in for follow-up visits, you will do some "booster sessions" of your assigned brain training at home before the visits. To participate, you will need to have a study partner who is close to you and who can speak with the study team about how you are doing while you are taking part in the study. Your study partner will need to come to our clinic with you one time to sign the consent form, but then they can complete all of their study interviews by phone. We will pay you for your time on the study. You will be compensated $75 for the screening visit, then $100 for each follow-up visit (5 visits) and $100 per MRI scan (2 scans). Study partners will receive $50 for the initial visit to sign consent and complete the first interview, and they will then be compensated $25 for each subsequent phone interview (4 interviews).

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 trial.

Principal Investigator

Pudugramam
Doraiswamy

Protocol Number

PRO00116036

Phase

N/A

Enrollment Status

Pending Open to Enrollment