Have you or your loved ones been diagnosed with alzheimer dementia?
You may be eligible to participate in a alzheimer dementia clinical trial.
Have you or your loved ones been diagnosed with alzheimer dementia? You may be eligible to participate in a alzheimer dementia clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Alzheimer Dementia Clinical Trial in Greifswald Mecklenburg-Vorpommern
Have you or your loved ones been diagnosed with alzheimer dementia?
You may be eligible to participate in a alzheimer dementia clinical trial.
Have you or your loved ones been diagnosed with alzheimer dementia? You may be eligible to participate in a alzheimer dementia clinical trial.
Terminated
Male & Female
55 - 85
Years old
Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor.
Details for the study
Brief Title
Immunoadsorption for Treatment of Alzheimer's Disease
Official Title
Efficacy of Immunoadsorption for Treatment of Persons With Alzheimer Dementia and Agonistic Autoantibodies Against alpha1A-adrenoceptor (IMAD)
Brief Summary
Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic <br /> autoantibodies against alpha1A-adrenoceptor.
Detailed Description
The IMAD trial outlined aims to ascertain whether the positive effects of immunoadsorption
(IA) on slowing down dementia progression, shown in a pilot trial, can be replicated in a
slightly larger number of subjects and to comprehensively investigate the effects by a
combination of brain and vessel imaging along with cognitive tests and further
state-of-the-art cardiovascular, cerebrovascular and laboratory examinations. If the trial
results underpin the hypothesis that IA effectively counteracts pathophysiological
impairments and dementia-related cognitive decline, it may open up a new treatment approach
against dementia, namely the reversal or avoidance of further vascular damage by the removal
of agonistic autoantibodies (agAAB) in agAAB-positive persons.
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.
Treatments and/or Procedures
Immunoadsorption with globaffin
Immunoadsorption for treatment of persons with Alzheimer Dementia
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Changes in cerebral blood flow, estimated by Arterial Spin Labeling MRI
Measurement of cerebral blood flow and evaluation of changes between baseline and condition after intervention over a 12 months period
Secondary
Laboratory parameters in liquor associated with Alzheimer's disease
Measurement of beta-amyloid and tau species concentrations in liquor (optional; only if subjects gave informed consent in lumbar puncture)
Secondary
Renal function
Estimated glomerular Filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula
Secondary
Renal function
Nephrosonography: position, size and surface of kidneys, echogenicity, presence and assessment of cysts and tumors, calcifications, nephroliths
Secondary
Vascular effects
Oxygen saturation: transcutaneous oxygen pressure examinations by PRÉCISE 8008, Medicap
Secondary
Vascular effects
Arterial stiffness: measurement by Mobil-O-Graph (pulse wave analysis)
Secondary
Vascular effects
Left ventricular ejection fraction (LVEF)
Secondary
Vascular effects
Endothelial function: measurement by Endo-PAT
Secondary
Cognition (changes/improvement/impairment)
Measurement by Benton Test
Secondary
Cognition (changes/improvement/impairment)
Measurement by California Verbal Learning Test (CVLT)
Secondary
Cognition (changes/improvement/impairment)
Measurement by Mini Mental Status Examination-2 (MMSE)
Secondary
Cognition (changes/improvement/impairment)
Measurement by Alzheimer's Disease Assessment Scale (ADAS-cog)
Secondary
Vascular effects
Arterial stiffness: measurement by Endo-PAT
Other
Serum analytics
analysis of agonistic autoantibodies against alpha1A adrenoceptor and measurement of different biomarkers, metabolites associated with Alzheimer's disease in blood samples
Study Criteria
Inclusion Criteria:
- 55-85 years of age
- 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:
- Haemanalysis:
- 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