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

Study Overview
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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.

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.

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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Deep brain stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo<br>Stimulator setting is OFF | Other: Deep brain stimulation<br>* DBS in the Nucleus basalis Meynert<br>|
| Active Comparator: Deep Brain Stimulation<br>Stimulator setting is ON | Other: Deep brain stimulation<br>* DBS in the Nucleus basalis Meynert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive improvement | improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests | one- year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of the optimal stimulation parameter |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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(light to moderate)