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

Phase 2

• Conditions: E11; F00; Type 2 diabetes mellitus; Dementia in Alzheimer disease

• Registration Number: DRKS00003133
• Lead Sponsor: niversitätsklinikum Essen45147 Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-14
• Study Completion: 2015-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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;
CDR=0;
No impairment of activities of daily living (ADL);
Declarative memory in the delayed reproduction of word lists of CERDAplus <-1 and in the delayed recall in WMS-R subtest logical memory” <-1;
In the parts not regarding cognitive function performance of CERADplus <-1 on average and no item <-2.

Exclusion Criteria

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified