Study Summary
This trial will test if the DREAM program can help African Americans with poorly controlled diabetes and mild cognitive decline. The primary outcome is decline in verbal memory over 2 years, and follow-up data will be collected at 6, 12, 18, and 24 months.
- Diabetes
- Mild Cognitive Impairment
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 24 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Enhanced Usual Care (EUC)
1 of 2
Diabetes Regulation for Eyesight and Memory (DREAM)
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: Diabetes Regulation for Eyesight and Memory · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 65+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Pennsylvania | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Thomas Jefferson University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
- Casten R, Leiby BE, Kelley M, Rovner BW. A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment. Contemp Clin Trials. 2022 Oct 28;123:106977. doi: 10.1016/j.cct.2022.106977. [Epub ahead of print]
- Casten R, Leiby BE, Kelley M, Rovner BW. A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment. Contemp Clin Trials. 2022 Oct 28;123:106977. doi: 10.1016/j.cct.2022.106977. Online ahead of print.
- Casten R, Leiby BE, Kelley M, Rovner BW. A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment. Contemp Clin Trials. 2022 Dec;123:106977. doi: 10.1016/j.cct.2022.106977. Epub 2022 Oct 28.
- Barry Rovner 2021. "Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans With Diabetes and Mild Cognitive Impairment: A Randomized Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04259047.
Frequently Asked Questions
How many participants is this trial recruiting?
"Affirmative. According to clinicaltrials.gov, the trial which was initially advertised on October 25th 2021 is still actively looking for 200 patients from a single medical facility. The post was last amended December 15th of this year." - Anonymous Online Contributor
Has the FDA certified Diabetes Regulation for Eyesight and Memory?
"The safety of Diabetes Regulation for Eyesight and Memory was rated a 2 due to the phase two status, meaning that efficacy has yet to be demonstrated in clinical trials but there is some safety data available." - Anonymous Online Contributor
Are there any available slots for prospective participants in this trial?
"Affirmative. Clinicaltrials.gov has data demonstrating that the medical experiment, which was first posted on October 25th 2021, is still recruiting participants. 200 people are needed to be enrolled from 1 centre of research." - Anonymous Online Contributor