Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
11 participants
INTERVENTIONAL
2016-09-15
2020-10-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Amyloid-β Clearance Mechanisms in Alzheimer's Disease
NCT05059158
Molecular PET Imaging and Plasma Biomarkers in Alzheimer´s Disease and Other Neurodegenerative Diseases
NCT06731842
MRI of Alzheimer's Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems
NCT00413621
Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain
NCT00287248
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
NCT03307993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this study is (beside of safety) to demonstrate the stop of the vascular remodeling and cognition decline by immunoadsorption, a therapeutic method which is well established in cardiology and nephrology.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immunoadsorption with Globaffin for Alzheimer Dementia
Immunoadsorption with Globaffin
Immunoadsorption with Globaffin
Immunoadsorption for treatment of persons with Alzheimer Dementia
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immunoadsorption with Globaffin
Immunoadsorption for treatment of persons with Alzheimer Dementia
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Alzheimer's disease
* Presence of agAAB against alpha1-adrenoceptor
* Mini mental state examination (MMSE) score between 19 and 26
* Written informed consent given
Exclusion Criteria
* Presence of autoantibodies against the N-methyl-D-aspartate (NMDA) receptor
* Defective blood coagulation at time of inclusion
* Severe protein deficiency disorders
* manifest Vitamin/Folic acid deficiency (substitution allowed)
* Active infectious disease, or signs of ongoing infection with C-reactive protein (CRP) \>10mmol/L
* Impaired renal function (serum creatinine \>220 μmol/L)
* Any disease requiring immunosuppressive drugs or therapeutic antibodies
* Non curative treated malignant disease or another life-threatening disease with poor prognosis (survival less than 2 years), except for basal-cell carcinoma
* Unstable angina pectoris, atrioventricular block (AV block) 2./3. degree or symptomatic sick sinus syndrome without implanted pacemaker, history of myocardial infarct, bypass or other revascularization measures, valvular heart defect (≥ 2. Degree)
* Severely reduced left ventricular systolic function (LVEF \< 30%) and/or heart failure symptoms according to New York Heart Association (NYHA) class III/IV
* Clinical manifestation of arterial disease, vascular surgery: No Arteria Carotis Interna (ACI) Stenosis \> 60%, peripheral artery occlusive disease (PAOD) \> IIb, NASCET, no clinical manifest apparent stroke in anamnesis, MRI: no diffusion disorder, no expired territorial stroke
* Endocrine disorder excluding diabetes mellitus
* Severe hepatic damages (CHILD-Score \< 4)
* Severe mental disorders (bipolar disorder, schizophrenia, depression) requiring treatment
* Alcohol or drug abuse
* Drug therapy against dementia since less than 3 months
* Psychopharmacological drug therapy since less than 3 months
* Dialysis requirement
* MRI contraindications (e.g. heart pacemaker)
* Legal tutelage
* Previous treatments with IA or immunoglobulin
* Inability to undergo the study procedure (IA on five consecutive days with subsequent Immunoglobulin G (IgG) substitution)
* treatment with angiotensin-converting-enzyme inhibitors (ACE inhibitors) during the IA (angiotensin receptor blockers (AT-blockers) possible)
* Participation in any other clinical/interventional study within less than 30 days prior to screening date
55 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Medicine Greifswald
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcus Dörr, Prof.Dr.med.
Role: PRINCIPAL_INVESTIGATOR
University Medicine Greifswald
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIV-16-02-014668
Identifier Type: OTHER
Identifier Source: secondary_id
201503IMAD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.