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Clinical Trials/EUCTR2018-000342-19-DE
EUCTR2018-000342-19-DE
Active, not recruiting
Phase 1

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 sites40 target enrollmentAugust 20, 2018
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ConditionsIncluded 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]
DrugsCurazink

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 20, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät

Eligibility 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 \= \<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:

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;

Outcomes

Primary Outcomes

Not specified

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