NCT01094145

Brief Summary

In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

March 25, 2010

Last Update Submit

June 6, 2013

Conditions

Alzheimer Disease

Keywords

(light to moderate)

Outcome Measures

Primary Outcomes (1)

  • cognitive improvement

    improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests

    one- year

Secondary Outcomes (1)

  • determination of the optimal stimulation parameter

    one year

Study Arms (2)

Placebo

SHAM COMPARATOR

Stimulator setting is OFF

Other: Deep brain stimulation

Deep Brain Stimulation

ACTIVE COMPARATOR

Stimulator setting is ON

Other: Deep brain stimulation

Interventions

Deep brain stimulationOTHER

DBS in the Nucleus basalis Meynert

Deep Brain StimulationPlacebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • German speaking male/female subjects
  • age:60-80
  • AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale
  • no Lewy-Body-dementia or other form of dementia
  • MMST \>18 and \<26
  • stable psychopharmacological medication
  • no psychotic symptoms, no suicidal tendency
  • education for at least 8 years
  • written informed consent of the patient
  • consent of at least two family members
  • no contraindication regarding PET-examination
  • no contraindication regarding anesthesia or stereotactic operation

You may not qualify if:

  • legal accommodation
  • clinical co-morbidity
  • contraindication of MRT examination
  • psychotic symptoms last six months
  • aggressive behavior or suicidal tendency
  • verbal IQ \<85
  • stereotactic operation in previous history
  • neoplastic neurological diseases
  • serious organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uni-Klinik Köln AöR

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.

    PMID: 26827109DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Volker Sturm, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

  • Jens Kuhn, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

  • H. J. Freund, Prof. Dr. med.

    Stellvertretender Leiter der Klinischen Prüfung Institut für Neurowissenschaften und Medizin (INM-7) Forschungszentrum Jülich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jens Kuhn

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

DE(1)