Early Alzheimer´s dementia (eAD), type 2 diabetes mellitus with amnestic mild cognitive impairment (T2D-aMCI), healthy controls (Co) MedDRA version: 17.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: NovoRapid
Pharmaceutical Form: Nasal spray
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: ad (1): Moderate to severe AD (MMSE 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It should be proofed that the intranasal application of the IMP is an enhancement for patients with early Alzheimer's dementia concerning their declarative recall. ;Primary end point(s): The primary outcome is the change in delayed recall from baseline to performance after 8 weeks of intranasal treatment with rapid-acting insulin analogue insulin aspartate (ASP-I) or placebo.;Timepoint(s) of evaluation of this end point: Visit 3,5 and 9 (declarative immediate recall) Visit 4,6 and 10 (declarative delayed recall);Secondary Objective: Investigate the effect of intranasal Inuslin to 1) advanced cognitive performance parameter 2) the time interval that is experiencing a possible improvement in cognitive performance 3) neuronal and glial metabolites measured by proton magnetic resonance spectroscopy (1H MRS) 4) food intake, body weight and Body fat 5) How long is the memory performance effected by intranasal inulin in patients with early Alzheimer's dementia, in pts with type 2 diabetes mellitus and in control subjects at the follow-up investigation? What implications can be found in the follow-up examination? 6) Effect of intranasal insulin on the Neuroproteomics and the Neurometabolom compared to the baseline examination. Representation of possible pathogenic mechanisms for the identification of targets for new therapeutic approaches. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. 8 weeks after treatment with IMP 2. visit 4,6,8,10,12 and 14 3. visit 3,10 and 14 4. see protocol table 1 5. see protocol table 1 6. screening and visit 10 7. screening and visit 10;Secondary end point(s): 1. Declarative immediate recall after 8 weeks treatment with IMP 2. Changes in advanced cognitive ability 3. Changes measured via MR-spectroscopy 4. Changes in blood-based biochemic parameters and physical parameters 5. Changes in blood-based biochemic parameters which are relevant concerning safety of the IMP 6. Planed neuroproteomic analyse 7. Neurometabolic profile of the liquor | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Norbert Scherbaum
Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen
Outcome results
None listed