Electroconvulsive Therapy for Treatment of Alzheimer´s Disease

NCT02438202 | Not Yet Recruiting

• 1 other identifier: ECTAD
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Cognition

  individual change between initial and final MiniMentalStateExamination (MMSE)

  27 weeks

Secondary Outcomes (3)

• Change in Mood

  27 weeks

• Change in Cognition

  27 weeks

• Deterioration in Cognition

  27 weeks

Study Arms (1)

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).

Device: Thymatron IV device (Somatics)

Interventions

Thymatron IV device (Somatics) DEVICE

Patients will be treated with a modified routine ECT/maintenance ECT series.

Electroconvulsive Therapy (ECT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alexander Sartorius, MD, PhD

  Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH), Medical Faculty Mannheim, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Sartorius, MD, PhD

CONTACT

+49-621-1703; alexander.sartorius@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 8, 2015
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-04