AUTHOR=Sugimoto Taiki , Araki Atsushi , Fujita Hiroki , Honda Keiko , Inagaki Nobuya , Ishida Takeshi , Kato Junichi , Kishi Minoru , Kobayashi Kazuki , Kouyama Kunichi , Noma Hisashi , Ohishi Mitsuru , Satoh-Asahara Noriko , Shimada Hiroyuki , Sugimoto Kazuhiro , Suzuki Susumu , Takeya Yasushi , Tamura Yoshiaki , Tokuda Haruhiko , Umegaki Hiroyuki , Watada Hirotaka , Yamada Yuichiro , Sakurai Takashi 

TITLE=The Multi-Domain Intervention Trial in Older Adults With Diabetes Mellitus for Prevention of Dementia in Japan: Study Protocol for a Multi-Center, Randomized, 18-Month Controlled Trial

JOURNAL=Frontiers in Aging Neuroscience

VOLUME=13

YEAR=2021

URL=https://www.frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2021.680341

DOI=10.3389/fnagi.2021.680341

ISSN=1663-4365

ABSTRACT=<p><bold>Background:</bold> The Japan-Multi-domain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes (J-MIND-Diabetes) is an 18-month, multi-centered, open-labeled, randomized controlled trial designed to identify whether multi-domain intervention targeting modifiable risk factors for dementia could prevent the progression of cognitive decline among older adults with type 2 diabetes mellitus (T2DM). This manuscript describes the study protocol for the J-MIND-Diabetes trial.</p><p><bold>Materials and Methods:</bold> Subjects of this trial will comprise a total of 300 T2DM outpatients aged 70–85 years with mild cognitive impairment. Subjects will be centrally randomized into intervention and control groups at a 1:1 allocation ratio using the stratified permuted-block randomization methods. The intervention group will participate in multi-domain intervention programs aimed at: (1) management of metabolic and vascular risk factors; (2) physical exercise and self-monitoring of physical activity; (3) nutritional guidance; and (4) social participation. The control group will receive usual T2DM care and general instructions on dementia prevention. The primary and secondary outcomes will be assessed at baseline, at 6- and 18-month follow-up. The primary outcome is change from baseline at 18 months in a global composite score combining several neuropsychological domains, including global cognitive function, memory, attention, executive function, processing speed and language. Secondary outcomes include: (1) cognitive changes in neuropsychological tests; (2) changes in geriatrics assessments; (3) metabolic control and diabetic complications; (4) changes in blood and urinary markers.</p><p><bold>Discussion:</bold> This trial will be the first trial to demonstrate the effectiveness of multi-domain intervention in preventing cognitive decline in older adults with T2DM at increased risk of dementia in Japan.</p><p><bold>Trial Registration:</bold> UMIN000035911; Registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 18 February 2019. (<ext-link ext-link-type="uri" xlink:href="https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908" xmlns:xlink="http://www.w3.org/1999/xlink">https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908</ext-link>).</p>