Investigation of the significance of neuronal antibodies in patients with cognitive disorders and therapy with immunoadsorption (IA)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016017

Enrollment

Registered

2018-12-21

Start date

2019-01-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F03 G04.8

Interventions

Group 1: Patients with cognitive disorders and detection of neuronal autoantibodies will be included. These patients will undergo immunoadsorption. Before and avert immunoadsorption patients will comp

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with cognitive disorders presenting at charité university hospital Berlin who undergo an autoantibody screening and are treated with IA

Exclusion criteria

Exclusion criteria: other severe or untreated medical, neurological or psychiatric disease, drug abuse or intensive care treatment

Design outcomes

Primary

Measure	Time frame
Comparison of IA with control in the efficacy of therapy of patients with cognitive disorders and neuronal autoantibodies Functional tests include: •Mini Mental State Examination (Folstein et al, 1975) •CDR-SB Score (Clinical Dementia Rating) •ADAS-Cog Test (Alzheimer's disease assessment scale cognitive) •Hamburg Wechsler Intelligenz Test for adualts, HAWIE,(Tewes,1994), • word fluency (phonematic and semantic, Aschenbrenner et al., 2000) • Short-term memory (verbal: Zahlennachsprechen; visuell-räumlich: „Corsi block tapping“, Orsini, 1994), • visual-spacial memory (Rey-Figur, Shin et al., 2006), • cognitive processing speed and divided attention (TMT-A & TMT-B, Reitan, 1958), • Visual Analogue Mood Scales, (VAMS, Stern, 1997) •Modified Rankin Scale (mRS)	—

Measure

Time frame

Comparison of IA with control in the efficacy of therapy of patients with cognitive disorders and neuronal autoantibodies Functional tests include: •Mini Mental State Examination (Folstein et al, 1975) •CDR-SB Score (Clinical Dementia Rating) •ADAS-Cog Test (Alzheimer's disease assessment scale cognitive) •Hamburg Wechsler Intelligenz Test for adualts, HAWIE,(Tewes,1994), • word fluency (phonematic and semantic, Aschenbrenner et al., 2000) • Short-term memory (verbal: Zahlennachsprechen; visuell-räumlich: „Corsi block tapping“, Orsini, 1994), • visual-spacial memory (Rey-Figur, Shin et al., 2006), • cognitive processing speed and divided attention (TMT-A & TMT-B, Reitan, 1958), • Visual Analogue Mood Scales, (VAMS, Stern, 1997) •Modified Rankin Scale (mRS)

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Secondary

Measure	Time frame
Secondary endpoints: 1. Effect of IA on the structure of the gray and white brain matter as well as on functional networks, measured by structural and functional (blood-oxygen level dependent, „BOLD“) MRI. 2. Safety of IA in patients with high titer autoantibodies is comparable to historic patient groups. 3. extent of the reduction of autoantibodies in cerebrospinal fluid (CSF) and serum 4. alteration microRNA Profils in CSF by IA Secondary hypothesis: 1. IA has an influence on structure and function of the brain, especially a reversibility of alterations in tracteography and resting state MRI caused by the inflammation. 2. Tolerance of IA in patients with high titer autoantibodies is comparable to historic patient collectives concerning allergic reactions, Blood pressure and safety (catheter infections). All these parameters will be evaluated in the course of this study. 3. Antibodies are, due to their pathogen pattern surrogate markers for disease activity. Therefore reduction of autoantibody levels should correlate with dieses stage. 4. Pre and post IA we will evaluate a profiles of microRNAs in the CSF and compare them. MicroRNAs are increasingly important as regulation molecules in alteration of neurons (Zhang Y et al. 2017, Nature) and play an important role in dementias (van Harten AC et al. 2015). in case of clinical improvement we Santo identify microRNAs that can serve as markers for cognitive improvement and could be useful for further diagnostics as well as therapy monitoring.	—

Measure

Time frame

Secondary endpoints: 1. Effect of IA on the structure of the gray and white brain matter as well as on functional networks, measured by structural and functional (blood-oxygen level dependent, „BOLD“) MRI. 2. Safety of IA in patients with high titer autoantibodies is comparable to historic patient groups. 3. extent of the reduction of autoantibodies in cerebrospinal fluid (CSF) and serum 4. alteration microRNA Profils in CSF by IA Secondary hypothesis: 1. IA has an influence on structure and function of the brain, especially a reversibility of alterations in tracteography and resting state MRI caused by the inflammation. 2. Tolerance of IA in patients with high titer autoantibodies is comparable to historic patient collectives concerning allergic reactions, Blood pressure and safety (catheter infections). All these parameters will be evaluated in the course of this study. 3. Antibodies are, due to their pathogen pattern surrogate markers for disease activity. Therefore reduction of autoantibody levels should correlate with dieses stage. 4. Pre and post IA we will evaluate a profiles of microRNAs in the CSF and compare them. MicroRNAs are increasingly important as regulation molecules in alteration of neurons (Zhang Y et al. 2017, Nature) and play an important role in dementias (van Harten AC et al. 2015). in case of clinical improvement we Santo identify microRNAs that can serve as markers for cognitive improvement and could be useful for further diagnostics as well as therapy monitoring.

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Countries

Germany

Contacts

Public ContactHarald Prüß

Klinik für NeurologieCharité - Universitätsmedizin Berlin

harald.pruess@charite.de+49-30-450560399

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026