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Thymatron IV device (Somatics) / Alzheimer's Disease · Interventional Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned but not yet recruiting pilot study testing whether electroconvulsive therapy (ECT) can improve cognition in Alzheimer's disease patients over 27 weeks. The study is based on preclinical and mechanistic hypotheses (BDNF elevation, hippocampal gray matter preservation) and prior case experience, but no efficacy data are available from this registry record.
Interventional, Single Group, Open label, Treatment purpose. Alzheimer's Disease; age from 65 Years. Intervention: Electroconvulsive Therapy (ECT). n = 15. Central Institute of Mental Health, Mannheim (presumed to be Germany, based on institution name); exact multicenter status not specified..
This is a planned but not yet recruiting pilot study testing whether electroconvulsive therapy (ECT) can improve cognition in Alzheimer's disease patients over 27 weeks. The study is based on preclinical and mechanistic hypotheses (BDNF elevation, hippocampal gray matter preservation) and prior case experience, but no efficacy data are available from this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
No clinical impact can be assessed because results are not yet available. Readers should recognize this as a very early-stage exploratory study designed to generate preliminary data and mechanistic insight, not to establish efficacy.
This is a pilot study registration with no results posted; it is designed to test a novel hypothesis about ECT in Alzheimer's disease, too early to provide clinical evidence of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed because results are not yet available. Readers should recognize this as a very early-stage exploratory study designed to generate preliminary data and mechanistic insight, not to establish efficacy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02438202). This is a study registration, not published results. Lead sponsor: Central Institute of Mental Health, Mannheim. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 15 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DEVICE: Thymatron IV device (Somatics). Primary outcome measures: Change in Cognition , 27 weeks. 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.
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