Alzheimer Disease Clinical Trial
Official title:
Deep Brain Stimulation of the Nucleus Basalis Meynert 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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