Alzheimer Disease
Conditions
Keywords
(light to moderate)
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.
Detailed 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.
Interventions
OTHERDeep brain stimulation
DBS in the Nucleus basalis Meynert
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive improvement | one- year | improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests |
Secondary
| Measure | Time frame |
|---|---|
| determination of the optimal stimulation parameter | one year |
Countries
Germany
Outcome results
None listed