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Trial record 6 of 651 for:    Alexander Disease

Electroconvulsive Therapy for Treatment of Alzheimer´s Disease (ECTAD)

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ClinicalTrials.gov Identifier: NCT02438202
Recruitment Status : Not yet recruiting
First Posted : May 8, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Brief Summary:

Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific and severe psychiatric disorders) and extremely safe modern treatment option.

Alzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by progressive cognitive deterioration accompanied by declining activities of daily living, by a variety of behavioral disturbances and by neuropsychiatric symptoms. The clinical progression of disease can be delayed by pharmaceutical therapies like acetylcholinesterase inhibition (e.g. rivastigmine) for 6 to 12 months at most.

Along with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived neurotrophic factor (BDNF) level is since recently being considered as a negative predictor for the further disease course. In animal experimental studies it was possible to arrest the disease progression with the aid of neurotrophic substances. Many single studies, but also a number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and medial temporal brain regions.

Strikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists for gray matter volume gain after an ECT series, especially for the hippocampus.

There is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on the basis of following indications: a) affective disorders and b) behavioral disturbances. A positive effect of ECT on the symptoms of agitation and aggression was assessed in AD patients alongside with a very good tolerability.

To investigate the potential salutary effects of ECT on AD the investigators designed a pilot study with the following concept: Patients with a confirmed AD diagnosis and preexisting stable antidementia medication over at least 6 months will receive a modified maintenance ECT over a total of 27 weeks.

In the proposed pilot study, the investigators hypothesize that cognitive functioning of AD patients will improve significantly and independently from affective symptoms, when initial and final examinations are compared. The affirmation of the hypothesis would provide not only further insight into the mechanism of action of ECT but also a very important reference point for the development of new treatment options for a so-far incurable disease.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Device: Thymatron IV device (Somatics) Not Applicable

Detailed Description:

Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific and severe psychiatric disorders) and extremely safe modern treatment option.

Alzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by progressive cognitive deterioration accompanied by declining activities of daily living, by a variety of behavioral disturbances and by neuropsychiatric symptoms. All currently available treatments remain palliative in nature. The clinical progression of disease can be delayed by pharmaceutical therapies like acetylcholinesterase inhibition (e.g. rivastigmine) for 6 to 12 months at most.

Along with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived neurotrophic factor (BDNF) level is since recently being considered as a negative predictor for the further disease course. In animal experimental studies it was possible to arrest the disease progression with the aid of neurotrophic substances. Many single studies, but also a number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and medial temporal brain regions.

Strikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists for gray matter volume gain after an ECT series, especially for the hippocampus.

There is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on the basis of following indications: a) affective disorders and b) behavioral disturbances. A positive effect of ECT on the symptoms of agitation and aggression was assessed in AD patients alongside with a very good tolerability. A recent review on ECT treatment in patients with concomitant depression and AD pointed out that these patients have significantly better scores in cognitive tests 6 months after the ECT series.

ECT as a psychiatric treatment for cognitive enhancement in AD is uncharted scientific territory.

To investigate the potential salutary effects of ECT on AD the investigators designed a pilot study with the following concept: Patients with a confirmed AD diagnosis and preexisting stable antidementia medication over at least 6 months will receive a modified maintenance ECT over a total of 27 weeks.

In the proposed pilot study, the investigators hypothesize that cognitive functioning of AD patients will improve significantly and independently from affective symptoms, when initial and final examinations are compared. The affirmation of the hypothesis would provide not only further insight into the mechanism of action of ECT but also a very important reference point for the development of new treatment options for a so-far incurable disease.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electroconvulsive Therapy for Treatment of Alzheimer´s Disease
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Electroconvulsive Therapy (ECT)
A modified Electroconvulsive Therapy Series in Patients with Alzheimer's Disease. Device for the intervention ECT will be the Thymatron IV device (Somatics, LLC. Lake Bluff, Illinois, USA).
Device: Thymatron IV device (Somatics)
Patients will be treated with a modified routine ECT/maintenance ECT series.



Primary Outcome Measures :
  1. Change in Cognition [ Time Frame: 27 weeks ]
    individual change between initial and final MiniMentalStateExamination (MMSE)


Secondary Outcome Measures :
  1. Change in Mood [ Time Frame: 27 weeks ]
    individual change between initial and final Hamilton Depression Scale (HAMD) score. This will also enable to use the secondary outcome as a covariate of the primary outcome variable

  2. Change in Cognition [ Time Frame: 27 weeks ]
    Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)

  3. Deterioration in Cognition [ Time Frame: 27 weeks ]
    Delirium Rating Scale-Revised-98 (DRS-R98)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of Alzheimer's disease (Mini Mental State Examination >5 and <26)
  • routine treatment of AD due to German national guidelines ("S3-Leitlinie")
  • Ability to consent. If in doubt an independent (from the study) psychiatrist has to document ability to consent. If no ability to consent is stated, a legal guardian can consent instead. No ECT will be performed against the patient's will.

Exclusion Criteria:

  • contraindications for ECT
  • current major depressive episode due to DSM IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438202


Contacts
Contact: Alexander Sartorius, MD, PhD +49-621-1703 ext 2913 alexander.sartorius@zi-mannheim.de

Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Alexander Sartorius, MD, PhD Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH), Medical Faculty Mannheim, University of Heidelberg

Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02438202     History of Changes
Other Study ID Numbers: ECTAD
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders