Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02438202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2015-04-29
Brief Title:
Electroconvulsive Therapy for Treatment of Alzheimers Disease
Sponsor:
Central Institute of Mental Health Mannheim
Organization:
Central Institute of Mental Health Mannheim
Study Overview
Official Title:
Electroconvulsive Therapy for Treatment of Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECTAD
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
Alzheimers 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 eg 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
Alzheimers 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 eg 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
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
Alzheimers 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 eg 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
Alzheimers 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None