Phase II prospective, randomized, double-blind clinical trial for the anti-inflammatory effects of an 8-week dose of Curazink (zinc histidine) in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease

Phase 2

• Conditions: F06.7; G30.1; Mild cognitive disorder; Alzheimer disease with late onset

• Registration Number: DRKS00015782
• Lead Sponsor: Otto-von-Giericke University MagdeburgMedical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-24
• Study Completion: 2022-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Patients with mild cognitive impairment and suspected Alzheimer's pathology according to NIA-AA criteria or patients with mild Alzheimer's dementia (MMST>= 18) according to NIA-AA criteria and in the presence of zinc deficiency or serum zinc concentrations in the lower normal range ( Zinc in the serum <=13 µmol / l, reference range: 9 - 18 µmol / l);
- Patients aged> 55 years;
- Patients or relatives must understand the goals of the study and the potential side effects;
- A willingness to consent must be given and a declaration of consent must be signed;
- Patients must have sufficient command of the German language in order to carry out the neuropsychological testing

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;
- CRP concentrations in plasma> 20 mg / l
- Patients with a history of underlying infectious diseases with possible neurological manifestations (syphilis, borreliosis);
- Patients with a history of chronic liver disease (hepatitis B, C, autoimmune hepatitis);
- Patients with unstable heart disease;
- patients with severe kidney disease;
- Patients with insulin-dependent type 2 diabetes mellitus
- 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 (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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- CRP concentration in the plasma (possible decrease of the inflammatory parameter)<br>- ADAS-cog (possible improvement of cognition)

Secondary Outcome Measures

Name	Time	Method
- plasma IL-6 concentration (possible decrease in the inflammatory parameter)<br>TGF-ß1, IL-10 in the plasma (possible increase in the concentration of anti-inflammatory cytokines)<br>- BDNF in the plasma (possible increase in the concentration of the neuroregenerative cytokine)<br>- immune status (blood count, possible change in immune cell populations)<br>- Zinc in serum (increase in concentration)<br>- MMST (possible increase in cognition)<br>- SF-36 (possible improvement of the general condition)<br>- Apolipoprotein E genotype