The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.
Type 2 diabetes mellitus (T2DM).
Aged 50-75 years (inclusive), male or female.
MMSE score >20 and <27,
CDR global score 0.5-1.0 (inclusive), with a CDR memory subscore ≥0.5,
Frontotemporal dementia (FTD) and its variants
Parkinson's disease (PD), dementia with Lewy bodies (DLB)
Progressive supranuclear palsy (PSP), corticobasal degeneration (CBD)
Multiple system atrophy (MSA), multiple sclerosis (MS), Huntington's disease (HD), etc.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Xiangya Hospital of Central South University
Collaborator
Huadong Hospital
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Changzhou No.2 People's Hospital
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator