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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Stimulator setting is OFF

Group Type SHAM_COMPARATOR

Deep brain stimulation

Intervention Type OTHER

DBS in the Nucleus basalis Meynert

Deep Brain Stimulation

Stimulator setting is ON

Group Type ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type OTHER

DBS in the Nucleus basalis Meynert

Interventions

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Deep brain stimulation

DBS in the Nucleus basalis Meynert

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No