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

Alzheimer Disease Clinical Trial

— MeynD-DBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094145
• Other study ID #: UK-09157
• Status: Completed
• Phase: N/A
• First received: March 25, 2010
• Last updated: June 6, 2013
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders

Intervention

Other:
• Deep brain stimulation
DBS in the Nucleus basalis Meynert

Locations

Country	Name	City	State
Germany	Uni-Klinik Köln AöR	Cologne	North Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive improvement	improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests	one- year	No
Secondary	determination of the optimal stimulation parameter		one year	No