DRKS00003133Active, not recruitingPhase 2
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 enrollmentStarted: June 14, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (—)
- Sex
- All
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;
- •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.
Investigators
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