NCT03132272

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4.1 years

First QC Date

November 16, 2016

Last Update Submit

March 4, 2021

Conditions

Alzheimer Dementia

Keywords

ADAsorb apheresisGlobaffin adsorberAgonistic AutoantibodiesImmunoadsorptionAlzheimer Dementia

Outcome Measures

Primary Outcomes (1)

  • 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

    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 at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

  • Cognition (changes/improvement/impairment)

    Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

  • Cognition (changes/improvement/impairment)

    Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

  • Cognition (changes/improvement/impairment)

    Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

  • Vascular effects

    Measurement at 4 times: before IA (= baseline), 1 month after IA, 6 months after IA, 12 months after IA

  • +7 more secondary outcomes

Other Outcomes (1)

  • Serum analytics

    12 months

Study Arms (1)

Immunoadsorption with Globaffin for Alzheimer Dementia

EXPERIMENTAL

Immunoadsorption with Globaffin

Device: Immunoadsorption with Globaffin

Interventions

Immunoadsorption with GlobaffinDEVICE

Immunoadsorption for treatment of persons with Alzheimer Dementia

Also known as: agonistic autoantibodies, alpha1A-adrenoceptor, Globaffin adsorber columns, ADAsorb apheresis
Immunoadsorption with Globaffin for Alzheimer Dementia

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Haemanalysis:
  • Presence of autoantibodies against the N-methyl-D-aspartate (NMDA) receptor
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Marcus Dörr, Prof.Dr.med.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

April 27, 2017

Study Start

September 15, 2016

Primary Completion

October 12, 2020

Study Completion

October 12, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)