Comparative study of the effect of intranasal insulin on memory deficits in type 2 diabetes and early Alzheimer´s dementia (INSULA) - INSULA

niversitätsklinikum Essen0 sitesAugust 10, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversitätsklinikum Essen

•group (1\) Early Alzheimer´s dementia (eAD), Mini Mental State Examination (MMSE) score 18\-25, aged 65 to 85 years of age; AD\-indicative biomarker pattern according to cerebrospinal fluid\-based neurochemical dementia diagnostics (CSF\-NDD); Clinical Dementia Rating score 1\.0; stable treatment with cholinesterase inhibitors for at least 3 months;
•group (2\) Type 2 diabetes mellitus and with amnestic mild cognitive impairment (T2D\-aMCI), 65 to 85 years of age, HbA1c 6\.5\-8\.0% on unchanged antidiabetic therapy during the foregoing 4 weeks, duration of diabetes \> 5 years; MCI according to the common network criteria; normal activities of daily living, amnestic MCI according to impaired objective memory function as assessed by CERAD word list delayed recall and WMS\-R logical memory, CDR\=0\.5
•group (3\) non\-MCI, non\-dementia controls (Co), aged 65 to 85 years
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 90

•ad (1\): Moderate to severe AD (MMSE \< 18; CDR \< 1\.0\); antidementive drug therapy other than cholinesterase inhibitors, other neurodegenerative diseases (e.g. Parkinson´s disease; dementia with Lewy bodies, frontotemporal lobe dementia), diabetes mellitus, abuse or addiction to psychoactive compounds (e.g. alcohol, benzodiazepines)
•ad (2\) T2D with frequent dysglycemic episodes (severe hypoglycemia or coma diabeticum during the foregoing 3 month, HbA1c \> 8\.0%), concomitant neurodegenerative diseases, otherwise the exclusion criteria apply which are valid for eAD (1\);
•Ad (3\): MCI, dementia, diabetes mellitus, neurodegenerative diseases; otherwise the exclusion criteria apply which are valid for eAD (1\) and T2D\-aMCI (2\), accept contraindications for CSF\-based neurochemical dementia diagnostics (CSF\-NDD), since CSF\-NDD will not be performed in controls.