Actively Recruiting
GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-03-05
420
Participants Needed
8
Research Sites
200 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
N
Nanjing First Hospital, Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes mellitus (T2DM)
- Age between 50 and 75 years, male or female
- Early symptomatic dementia (mild cognitive impairment or mild dementia) defined by MMSE score >20 and <27, CDR global score 0.5-1.0 with CDR memory subscore 0.5, and subjective memory complaints for 6 months or more
- Stable glycemic control for at least 3 months prior to screening, with either lifestyle/dietary intervention only or oral antidiabetic drugs with or without once-daily basal insulin
- HbA1c between 7.0% and 9.0% at screening
- Body mass index (BMI) of 20 kg/m2 or higher with stable weight (less than 5% fluctuation) for at least 3 months
- Stable treatment regimen for cognitive impairment for at least 3 months prior to screening, including no treatment, non-pharmacological therapy only, or approved symptomatic cognitive-enhancing medications excluding disease-modifying therapies for Alzheimer's disease
- Ability to comply with cognitive and functional assessments
- Understands and agrees to the trial protocol, signs informed consent, and will adhere to study requirements
You will not qualify if you...
- Evidence of other neurodegenerative diseases affecting cognition, excluding Alzheimer's disease, such as frontotemporal dementia, Parkinson's disease, dementia with Lewy bodies, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, multiple sclerosis, or Huntington's disease
- Current poorly controlled or unstable psychiatric disorders that may interfere with assessments or compliance
- PHQ-9 score of 10 or higher or GAD-7 score of 10 or higher at screening
- History of stroke, transient ischemic attack, or epileptic seizure within 3 months prior to screening; CNS disorders affecting cognition such as infections, tumors, metabolic encephalopathy, malnutrition-related neurological disorders, or severe brain injury
- Acute hyperglycemic or hypoglycemic events within 1 year, including diabetic ketoacidosis, hyperosmolar hyperglycemic state, or hypoglycemic coma
- Use of GLP-1 receptor agonists or related dual agonists within 3 months prior to screening
- Regular use of moderate-to-strong anticholinergic drugs within 4 weeks prior to screening or use of anti-Parkinsonian, antiepileptic, antipsychotic, morphine/opioid analgesics (except short-term use >5 days completed over 4 weeks before screening), CNS stimulants, or cannabis-related products within specified time frames
- Alcohol abuse exceeding defined weekly units
- Medical history of medullary thyroid carcinoma, pancreatitis, multiple endocrine neoplasia type 2, gallbladder or severe gastrointestinal disorders, active malignancy
- Uncontrolled or unstable diabetic retinopathy or maculopathy
- Severe organ dysfunction including elevated liver enzymes, reduced kidney function, or recent unstable heart conditions
- Known or suspected allergy to the study drug or related compounds
- Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
- MRI contraindications such as metal implants or claustrophobia
- Participation in other clinical trials within 3 months or conflicting medical research
- Any condition judged by the investigator to compromise safety or study assessments
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Department of Endocrinology, Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
2
Department of Endocrinology, Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Actively Recruiting
3
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
4
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
5
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Actively Recruiting
6
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Not Yet Recruiting
7
Department of Endocrinology, Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
8
Department of Endocrinology, Huadong Hospital Affiliated to Fudan University
Shanghai, China, 200040
Actively Recruiting
Research Team
Y
Yan Bi, MD, PhD
CONTACT
Z
Zhou Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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