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Completed

NCT Number: NCT01094145

Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uni-Klinik Köln AöR

Cologne, North Rhine-Westphalia, 50924, Germany

About this study

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. The stereotactic implantation of the electrodes will be guided by computerized tomography (CT) and magnetic resonance tomography (MRT).

Basically, even though deep brain stimulation is an invasive method, there are only few side effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement disorders (0,4-6%).

After the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. From the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between ON and OFF periods. Modifications of the stimulation parameter to obtain the best possible result are possible.

Throughout the one-year observation-period, the patients will be followed closely to monitor the effects of DBS on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Deep brain stimulation

Other

DBS in the Nucleus basalis Meynert

Primary outcomes

  1. cognitive improvement

    Time frame: one- year

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

Secondary outcomes

  1. determination of the optimal stimulation parameter

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease

Acronym: MeynD-DBS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2010
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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