Prospective, randomized, double-blind clinical trial phase II for the anti-inflammatory effects of Curazink (zinc histidine) for 8 weeks in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease - DEZINK

Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät0 个研究点目标入组 40 人开始时间: 2018年8月20日最近更新: 2020年8月18日

适应症

试验速览

暂无简介。

•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 = <13 µmol / l, reference range: 9 - 18 µmol / l);
•- in 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 (NIA-AA criteria [1]).
•- Patients with mild Alzheimer's dementia (MMST>= 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

•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);

发起方

Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät