Alzheimer DementiaIMADNCT03132272
Immunoadsorption for Treatment of Alzheimer's Disease
A study testing Immunoadsorption with Globaffin in people with Alzheimer Dementia, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Immunoadsorption with Globaffin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2016to 12 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Dementia
- Being tested
- Immunoadsorption with Globaffin
- Keywords
- ADAsorb apheresis, Globaffin adsorber, Agonistic Autoantibodies, Immunoadsorption, Alzheimer Dementia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorption with GlobaffinDevice
Also called agonistic autoantibodies, alpha1A-adrenoceptor, Globaffin adsorber columns, ADAsorb apheresis
Immunoadsorption for treatment of persons with Alzheimer Dementia
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption with Globaffin for Alzheimer Dementia | Experimental | Immunoadsorption with Globaffin Receives: Device: Immunoadsorption with Globaffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (12)
Cognition (changes/improvement/impairment)
Measurement by Alzheimer's Disease Assessment Scale (ADAS-cog)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA
Vascular effects
Endothelial function: measurement by Endo-PAT
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Measurement at 2 times: before IA (= baseline) and 12 months after IA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start15 Sep 2016
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Why it stopped: slow recruiting, difficulties in finding eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Dörr, Prof.Dr.med., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132272
- Sponsor's protocol ID
- 201503IMAD
- Other IDs
- CIV-16-02-014668
- Acronym
- IMAD
- Status last verified
- Mar 2021
- First submitted
- 16 Nov 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immunoadsorption for Treatment of Persons With Alzheimer Dementia and Agonistic Autoantibodies Against alpha1A-adrenoceptor (IMAD)
- ClinicalTrials.gov ID
- NCT03132272
- Acronym / sponsor ID
- IMAD / 201503IMAD
- Conditions
- Alzheimer Dementia
- Keywords
- ADAsorb apheresis, Globaffin adsorber, Agonistic Autoantibodies, Immunoadsorption, Alzheimer Dementia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruiting, difficulties in finding eligible patients
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption with Globaffin for Alzheimer Dementia | Experimental | Device: Immunoadsorption with GlobaffinImmunoadsorption with Globaffin |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- Haemanalysis:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoadsorption with GlobaffinAlso: agonistic autoantibodies, alpha1A-adrenoceptor, Globaffin adsorber columns, ADAsorb apheresisImmunoadsorption for treatment of persons with Alzheimer Dementia | Device | Immunoadsorption with Globaffin for Alzheimer Dementia |
Primary outcome
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
12 secondary outcomes
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
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
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
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
Vascular effects
Time frame: 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
Vascular effects
Time frame: 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
Vascular effects
Time frame: 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
Renal function
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
Time frame: Measurement at 2 times: before IA (= baseline) and 12 months after IA
Results and safety
The study was stopped early (reason given: slow recruiting, difficulties in finding eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Dörr, Prof.Dr.med. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoadsorption with Globaffin in people with Alzheimer Dementia, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruiting, difficulties in finding eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.