Included are patients with the presence of a moderate or pronounced zinc deficienc and the diagnosis of a mild cognitive disorder, which may be due to an additional investigation (amyloid PET and / or cerebrospinal fluid) in the context of already performed diagnostic clarification an Alzheimer's pathology.
Conditions
Interventions
Trade Name: Curazink
Product Name: Curazink
Pharmaceutical Form: Capsule, hard
CAS Number: 7440-66-6
Current Sponsor code: IIT-2017/02
Other descriptive name: ZINC
Concentration unit: mg milligram(s)
Sponsors
Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included are patients: - aged> 55 years - in the presence of a zinc deficiency or serum zinc concentrations in the lower normal range (zinc in the serum = = 18) according to NIA-AA criteria [2]. - Patients who understand the goals of the study and the potential side effects. - who are able to consent and sign the declaration of consent - who are sufficiently powerful in the German language to carry out the neuropsychological testing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: patients with a different cause of dementia than Alzheimer's disease; Patients with other severe neurological diseases (stroke, transient ischemic attack, brain tumor) in history; - Patients with chronic infectious underlying diseases with a possible neurological manifestation (syphilis, borreliosis) in the past history; - CRP> 20 mg / l - Patients with chronic liver disease (hepatitis B, C, autoimmune hepatitis) in history; - patients with unstable heart disease; - patients with severe kidney disease; - patients with insulin-dependent type 2 diabetes; - Patients with history of copper-bearing disease (Wilson's disease); - patients with acute infections; - patients with known allergy to Curazink; - Taking medication / drug groups that interact with Curazink according to the Specialist Information (11/2016): - tetracyclines, - ofloxacin, - other quinolones (ciprofloxacin, norfloxacin), D-penicillamine, DMPS ((RS) -2,3-disulfanylpropane-1-sulfonic acid), DMSA (dimercapto-succinic acid), EDTA (ethylenediamine tetraacetate), - Phosphates, iron, copper and calcium salts - Patient's participation in another clinical trial within the last 4 weeks prior to enrollment; - pregnant or breastfeeding women; - indications that the participant is unlikely to comply with the protocol (eg lack of cooperation);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary goal is to demonstrate the anti-inflammatory effect of Curazink based on the concentration of the C-reactive protein (CRP, acute phase protein). Under the 8-week treatment with Curazink (zinc histidine), a significant decrease in CRP plasma concentrations compared to placebo is expected. A second primary goal is to study the effect of Curazink on cognitive behavior (using Alzheimer's Disease Assessment Scale-Cognitive Subscale Test).;Primary end point(s): The first primary endpoint is the concentration of the C-reactive protein (CRP, acute phase protein). The second primary endpoint is the Alzheimer's Disease Assessment Scale Cognitive Subscale Test (ADAS-cog), which is expected to improve levels. The primary endpoints are tested in a hierarchical order and compared to placebo-group.;Timepoint(s) of evaluation of this end point: It should be statistically assessed whether under an 8-week therapy with Curazink: - there is a significant decrease in inflammatory parameters - there is a significant improvement in cognitive performance, - evidence of an improvement in the quality of life is. For this purpose, an inflammatory parameter (CRP) and a parameter of cognitive performance (ADAS-cog) are considered to be the primary endpoints and checked confirmatory hierarchically in this order. Further parameters of inflammation and parameters of cognitive performance as well as parameters of quality of life and results of follow-up examinations after 12 weeks are considered as secondary parameters and examined in the exploratory sense. Safety information is given descriptively.;Secondary Objective: Secondary objectives include studies on effects on immunological laboratory parameters, cognitive deficits and health-related quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include different immunological laboratory parameters as well as another cognitive test and assessment of health-related quality of life. Laboratory parameters: • Plasma proinflammatory cytokine levels: IL-6 • Levels of immunosuppressive cytokines in plasma: TGF-ß1, IL-10 • Concentrations of the neuromodulatory cytokine BDNF in the plasma • Blood • immune status / distribution of immune cell populations Apolipoprotein E genotype Cognitive tests: • Minimal Mental Status Test (MMST) Life quality: • Short Form (36) Health Questionnaire (SF-36) The Short Form (36) Health Questionnaire is a disease-non-specific measurement tool for assessing health-related quality of life. The SF-36 is often used in medicine for therapy control or history measurement.;Timepoint(s) of evaluation of this end point: It should be statistically assessed whether under an 8-week therapy with Curazink: - there is a significant decrease in inflammatory parameters - there is a significant improvement in cognitive performance, - evidence of an improvement in the quality of life is. For this purpose, an inflammatory parameter (CRP) and a parameter of cognitive performance (ADAS-cog) are considered to be the primary endpoints and checked confirmatory hierarchically in this order. Further parameters of inflammation and parameters of cognitive performance as well as parameters of quality of life and results of follow-up examinations after 12 weeks are considered as secondary parameters and examined in the exploratory sense. Safety information is given descriptively. | — |
Countries
Germany
Contacts
Public ContactDr. rer. nat. Antje Wiede
KKS Magdeburg, Med. Fakultät, OvGU Magdeburg
Outcome results
None listed