Comparative study on the effect of intranasal insulin on cognitive function in patients with type 2 diabetes and patients with early Alzheimer's Disease - INSULA

niversitätsklinikum Essen45147 Essen0 sites14 target enrollmentJune 14, 2011

Overview

No summary available.

Registry

who.int

Start Date

June 14, 2011

End Date

March 2, 2015

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversitätsklinikum Essen45147 Essen

•Group (1\):
•Patients with early Alzheimer’s disease (eAD); Mini\-Mental\-State\-Test (MMSE) 18 to 25 points;
•Clinical Dementia Rating (CDR) Score \= 1\.0; pretreatment with cholinesterase inhibitors for at least 3 months;
•Group (2\):
•Patients with type 2 diabetes and amnestic mild cognitive impairment (T2D\-aMCI);
•HbA1c 6\.5\-8\.0% with stable antidiabetic treatment for at least 4 weeks with duration of the disease \> 5 years;
•Amnestic MCI in according to the criteria of the Dementia Competence Network: impaired declarative memory in the delayed reproduction of word lists of CERADplus \<\-1 and in the delayed recall in WMS\-R subtest logical memory” \<\-1, in the parts not regarding cognitive function of CERADplus no performance \<\-2, CDR\=0\.5;
•No impairment of activities of daily living (ADL)
•Group (3\):
•Control persons without MCI, dementia and diabetes;

•Group (1\):
•Moderate or severe form of Alzheimer’s disease (MMSE\<18; CDR\>1\.0\);
•Antidementive pharmacotherapy other than cholinesterase inhibitors. Other neurodegenerative diseases (e.g. M. Parkinson, Lewy Body Dementia, frontotemporal dementia), diabetes mellitus, other possible reasons for an early Alzheimer’s disease; abuse or addiction to psychoactive substances (other than nicotine) e.g. alcohol or benzodiazepines; stroke or other heart diseases within 3 months before trial participation; insufficiently treated arterial hypertension; acute or chronic neuroinflammation; malignant tumor; moderate or severe form of major depression; suicidality; reasons for exclusion for MRT diagnostics.
•Group (2\):
•T2D with metabolic disturbances (severe hypoglycemia or diabetic coma during the last 3 months, HbA1c \> 8\.0%); neurodegenerative comorbidities; other possible reasons for an amnestic MCI than T2D (e.g. early Alzheimer’s disease, neuroendocrine or other metabolic disorders); familiar form of Alzheimer’s disease; or any other exclusion criteria apply to group 1\.
•Group (3\):
•MCI, dementia, diabetes mellitus, neurodegenerative disorders; any exclusion criteria apply to group 1 and 2\.