Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Immunoadsorption for treatment of persons with Alzheimer Dementia
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
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
Time frame: Measurement at 4 times over a 12 months period: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Measurement by Alzheimer's Disease Assessment Scale (ADAS-cog)
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Measurement by Mini Mental Status Examination-2 (MMSE)
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Measurement by California Verbal Learning Test (CVLT)
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Measurement by Benton Test
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Left ventricular ejection fraction (LVEF)
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
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Endothelial function: measurement by Endo-PAT
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Arterial stiffness: measurement by Endo-PAT
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Arterial stiffness: measurement by Mobil-O-Graph (pulse wave analysis)
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Oxygen saturation: transcutaneous oxygen pressure examinations by PRÉCISE 8008, Medicap
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Renal function
Nephrosonography: position, size and surface of kidneys, echogenicity, presence and assessment of cysts and tumors, calcifications, nephroliths
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Renal function
Estimated glomerular Filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula
Time frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
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)
Time frame: Measurement at 2 times: before IA (= baseline) and 12 months after IA