clinical trial or the anti-inflammatory effects of Curazink for 8 weeks in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease
- Conditions
- 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.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000342-19-DE
- Lead Sponsor
- Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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);
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method