Dysglycemia Clinical Trial
— DRINNOfficial title:
Long-acting Exenatide: a Tool to Stop Cognitive Decline in Dysglycemic Patients With Mild Cognitive Impairment?
Verified date | August 2021 |
Source | Azienda Ospedaliero-Universitaria di Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall objective of the study is to assess the potential effects of the long-acting GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2021 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 51 Years to 79 Years |
Eligibility | Inclusion Criteria: - patients capable of giving informed consent - dysglycemia/prediabetes defined as fasting plasma glucose between 100 and 125 mg/dl and/or 2-hour plasma glucose between 140 and 199 mg/dl after a 75 g OGTT and/or a HbA1c value between 5.7 and 6.4% - diagnosis of MCI according to the Petersen clinical criteria (the expected corrected scores at the MMSE are from 24 to 27) - age >50<80 yrs - stable medication for the past 3 months - Caucasian ethnicity Exclusion Criteria: - age <50>80 yrs - incapability to give informed consent - diabetes defined according to American Diabetes Association (ADA) criteria - clinically significant liver or kidney dysfunction defined as s-ALT > 2 times upper reference or estimated creatinine-clearance (eGFR) < 60 mL / min/1.73m2, assessed by with CKD-EPI formula - endocrinological diseases other than well controlled hypothyroidism, personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) syndrome, severe gastro-intestinal diseases (i.e gastroparesis, dumping syndromes), current or history of chronic or acute pancreatitis - any contraindication to the use of exenatide as per the Summary of Product Characteristics - known abuse of alcohol or drugs - ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body - significant neurologic disease other than MCI (i.e. Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy or head trauma) - BMI =22 Kg/m2 in subject = 70 yrs - MRI/CT showing unambiguous etiological evidence of cerebrovascular disease with regard to MCI - severe sensory defects; current presence of clinically significant psychiatric disorder - warfarin treatment, clinically significant systemic condition - history of cancer within the last 5 yrs - known allergy to exenatide or any of the other components. |
Country | Name | City | State |
---|---|---|---|
Italy | Center for Cognitive Disorders and Dementia AUSL of Parma and University of Parma | Parma | |
Italy | Endocrinology Unit | Parma |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma |
Italy,
Aviles-Olmos I, Dickson J, Kefalopoulou Z, Djamshidian A, Ell P, Soderlund T, Whitton P, Wyse R, Isaacs T, Lees A, Limousin P, Foltynie T. Exenatide and the treatment of patients with Parkinson's disease. J Clin Invest. 2013 Jun;123(6):2730-6. — View Citation
During MJ, Cao L, Zuzga DS, Francis JS, Fitzsimons HL, Jiao X, Bland RJ, Klugmann M, Banks WA, Drucker DJ, Haile CN. Glucagon-like peptide-1 receptor is involved in learning and neuroprotection. Nat Med. 2003 Sep;9(9):1173-9. Epub 2003 Aug 17. — View Citation
McClean PL, Hölscher C. Liraglutide can reverse memory impairment, synaptic loss and reduce plaque load in aged APP/PS1 mice, a model of Alzheimer's disease. Neuropharmacology. 2014 Jan;76 Pt A:57-67. doi: 10.1016/j.neuropharm.2013.08.005. Epub 2013 Aug 21. — View Citation
Perry T, Holloway HW, Weerasuriya A, Mouton PR, Duffy K, Mattison JA, Greig NH. Evidence of GLP-1-mediated neuroprotection in an animal model of pyridoxine-induced peripheral sensory neuropathy. Exp Neurol. 2007 Feb;203(2):293-301. Epub 2006 Nov 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of ADAS-cog Alzheimer's Disease Assessment Scale defined by ADAS-cog score at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the ADAS-Cog score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Mini Mental State Evaluation test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the Mini Mental State Evaluation (MMSE) score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Mini Mental State Evaluation quality test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the MMSE quality test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Phonemic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the Phonemic verbal fluency test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Semantic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the Semantic verbal fluency test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Geriatric Depression Scale (GDS) test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the GDS test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Clinical Dementia Rating Scale (CDR) test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the CDR test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Neuropsychiatric Inventory (NPI) test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the NPI test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Activities of Daily Living (ADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the ADL test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | Improvement of Instrumental Activities of Daily Living (IADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline | Absolute difference in the IADL test score compared to baseline in the 2 arms. | 16 and 32 weeks | |
Secondary | changes in structural and functional connectivity of neural networks as assessed by functional MRI (fMRI) at 16 (V2) and at 32 weeks (V3) | Before and after treatment voxel-wise brain maps will be statistically compared using Statistical Parametric Mapping, by a multivariate 2 x 2 ANOVA (experimental treatment /placebo x time pre/post) in order to observe changes in structural and functional connectivity of neural networks in relation to treatment | 16 and 32 weeks |
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