Alzheimer's DiseaseECTADNCT02438202
Electroconvulsive Therapy for Treatment of Alzheimer´s Disease
A study testing Thymatron IV device (Somatics) in people with Alzheimer's Disease, run by Central Institute of Mental Health, Mannheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Thymatron IV device (Somatics)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- contraindications for ECT
- current major depressive episode due to DSM IV
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Thymatron IV device (Somatics)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymatron IV device (Somatics)Device
Patients will be treated with a modified routine ECT/maintenance ECT series.
| Study group | Role | What they receive |
|---|---|---|
| Electroconvulsive Therapy (ECT) | Experimental | 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). Receives: Device: Thymatron IV device (Somatics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition
individual change between initial and final MiniMentalStateExamination (MMSE)
Measured: 27 weeks
Secondary outcomes (3)
Change in Mood
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
Measured: 27 weeks
Change in Cognition
Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)
Measured: 27 weeks
Deterioration in Cognition
Delirium Rating Scale-Revised-98 (DRS-R98)
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startDec 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Sartorius, MD, PhD, Principal investigator, Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH), Medical Faculty Mannheim, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438202
- Sponsor's protocol ID
- ECTAD
- Acronym
- ECTAD
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2015
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy for Treatment of Alzheimer´s Disease
- ClinicalTrials.gov ID
- NCT02438202
- Acronym / sponsor ID
- ECTAD / ECTAD
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 May 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electroconvulsive Therapy (ECT) | Experimental | Device: Thymatron IV device (Somatics)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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- contraindications for ECT
- current major depressive episode due to DSM IV
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 |
|---|---|---|
| Thymatron IV device (Somatics)Patients will be treated with a modified routine ECT/maintenance ECT series. | Device | Electroconvulsive Therapy (ECT) |
Primary outcome
Change in Cognition
Time frame: 27 weeks
individual change between initial and final MiniMentalStateExamination (MMSE)
3 secondary outcomes
Change in Mood
Time frame: 27 weeks
Change in Cognition
Time frame: 27 weeks
Deterioration in Cognition
Time frame: 27 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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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.
Alexander Sartorius, MD, PhD principal investigator
Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH), Medical Faculty Mannheim, University of Heidelberg
Questions about this trial
What is this clinical trial studying?
A study testing Thymatron IV device (Somatics) in people with Alzheimer's Disease, run by Central Institute of Mental Health, Mannheim.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Sartorius, MD, PhD (+49-621-1703 ext. 2913, alexander.sartorius@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognition (time frame: 27 weeks). 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 8 Sep 2026.