The effect of intranasal insulin on memory deficits in patients with diabetes type 2 and early Alzheimer dementia should be compared

• Conditions: Early Alzheimer´s dementia (eAD), type 2 diabetes mellitus with amnestic mild cognitive impairment (T2D-aMCI), healthy controls (Co); MedDRA version: 17.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 17.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-008555-41-DE
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-10
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified