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Electroconvulsive Therapy for Treatment of Alzheimer´s Disease

Study acronym: ECTAD
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Apr 2, 2025, no change to tracked fieldsv10-v11
  2. Notable Primary and study completion dates: Jan 2027 to Jan 2028
    • Start date: Dec 2024 to Dec 2026
    v9
  3. Notable Primary and study completion dates: Jan 2024 to Jan 2027
    • Start date: Dec 2021 to Dec 2024
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: Jan 2020 to Jan 2024
    • Start date: Dec 2019 to Dec 2021
    • Study completion date: Jan 2021 to Jan 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Dec 2018 to Dec 2019v5
  2. Notable Start date: Jan 2018 to Dec 2018v4
  3. Notable Primary completion date: Jul 2018 to Jan 2020
    • Start date: Jan 2016 to Jan 2018
    • Study completion date: Jul 2018 to Jan 2021
    v3
  4. Minor Study description expanded, about 2 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02438202
Lead Sponsor Central Institute of Mental Health, Mannheim
Conditions
(from sponsor)
Alzheimer's Disease
Related terms Alzheimer Disease
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov