Immunoadsorption for Treatment of Alzheimer's Disease (IMAD)

March 4, 2021 updated by: University Medicine Greifswald

Efficacy of Immunoadsorption for Treatment of Persons With Alzheimer Dementia and Agonistic Autoantibodies Against alpha1A-adrenoceptor (IMAD)

Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immunoadsorption with Globaffin for Alzheimer Dementia
Immunoadsorption with Globaffin
Device: Immunoadsorption with Globaffin
Immunoadsorption for treatment of persons with Alzheimer Dementia
Other Names:
  • agonistic autoantibodies
  • alpha1A-adrenoceptor
  • Globaffin adsorber columns
  • ADAsorb apheresis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in cerebral blood flow, estimated by Arterial Spin Labeling MRI
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
Measurement of cerebral blood flow and evaluation of changes between baseline and condition after intervention over a 12 months period
Measurement at 4 times over a 12 months period: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognition (changes/improvement/impairment)
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Measurement by Alzheimer's Disease Assessment Scale (ADAS-cog)
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Measurement by Mini Mental Status Examination-2 (MMSE)
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Measurement by California Verbal Learning Test (CVLT)
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Cognition (changes/improvement/impairment)
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Measurement by Benton Test
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Left ventricular ejection fraction (LVEF)
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Endothelial function: measurement by Endo-PAT
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Arterial stiffness: measurement by Endo-PAT
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Arterial stiffness: measurement by Mobil-O-Graph (pulse wave analysis)
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Oxygen saturation: transcutaneous oxygen pressure examinations by PRÉCISE 8008, Medicap
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Renal function
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Nephrosonography: position, size and surface of kidneys, echogenicity, presence and assessment of cysts and tumors, calcifications, nephroliths
Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Renal function
Time Frame: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Estimated glomerular Filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula
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
Time Frame: Measurement at 2 times: before IA (= baseline) and 12 months after IA
Measurement of beta-amyloid and tau species concentrations in liquor (optional; only if subjects gave informed consent in lumbar puncture)
Measurement at 2 times: before IA (= baseline) and 12 months after IA

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum analytics
Time Frame: 12 months
analysis of agonistic autoantibodies against alpha1A adrenoceptor and measurement of different biomarkers, metabolites associated with Alzheimer's disease in blood samples
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus Dörr, Prof.Dr.med., University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201503IMAD
  • CIV-16-02-014668 (Other Identifier: EUDAMED-No.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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