Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies

Inclusion Criteria:

• Male or female subjects (>50 years old) diagnosed with Dementia with Lewy bodies, in accordance with the consensus criteria for probable Dementia with Lewy bodies (McKeith et al., 1996) viii.
• NPI score ≥ 8 at screening
• MMSE ≥ 7 at screening
• Subjects living at home or in a residential or community care home. Subjects who live with or have regular daily visits from a responsible caregiver. Subjects must be able to read, write, and fully understand the language of the scales used in this trial.
• Subjects must exhibit sufficient visual, hearing, and communication capabilities
• The Informed Consent must be given by the subject and the subject’s legally acceptable representative.
• The informed consent must also be signed by the caregiver.
• CT or MRI within last 12 months – to be performed if not done

Exclusion Criteria:

• Neurodegenerative disorders such as Alzheimer’s disease, Frontotemporal dementia, including Pick’s disease, Korsakoff’s syndrome, Huntington’s chorea, Down’s syndrome, Creutzfeldt-Jacob disease and causes of Parkinsonism other than DLB.

• One of the following conditions possibly resulting in cognitive impairment:

  • Acute cerebral trauma, subdural hematoma and injuries secondary to chronic trauma (such as boxing).
  • Hypoxic cerebral damage whether or not due to acute or chronic cerebral hypoperfusion,
  • Vitamin deficiency state such as folate, vitamin B12 and other B complex deficiencies, e.g., thiamine deficiency in Korsakoff’s syndrome. Note: subjects taking regular B12 and folate are not necessarily excluded (treatment must be stable, ongoing for at least 4 weeks prior to entry).
  • Infection such as cerebral abscess, neurosyphilis, meningitis or encephalitis.
  • Primary or metastatic cerebral neoplasia.
  • Significant endocrine or metabolic disease e
  • Mental retardation or oligophrenia. Multi-infarct dementia or clinically active cerebrovascular disease

• Subjects with the following co-existing medical condition:

  • Any history of epilepsy or convulsions except for febrile convulsions during childhood.
  • Current clinically significant psychiatric disease, as judged by DSM-IV criteria, in particular current major depression or schizophrenia.
  • Peptic ulcer: if the ulcer is to be considered still “active”, i.e., treatment for this condition started <3 months ago or if treatment is not successful (still symptoms present), the subject is not eligible.
  • Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.
  • Current, clinically significant cardiovascular disease that would be expected to limit the subject’s ability to participate in and complete a 7-month trial.
  • Any agent being used for the treatment of dementia (approved, experimental or over the counter agents),
• History of drug or alcohol abuse within the last year or prior prolonged history.
• Female subject of childbearing potential without adequate contraception. Females who are breast-feeding are also excluded.
• Subjects who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.
• History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, bromide or the components of the drug under study.
• Subjects who have previously been enrolled in other galantamine HBr trials. Subjects who were screened for previous galantamine studies but not enrolled may be re-screened for this study.
• Subjects on antipsychotics other than Risperdal® (risperidone), Zyprexa® (olanzapine), Seroquel® (quetiapine), Geodon® (ziprasidone).
• Conditions that could interfere with the absorption of the compound or with the evaluation of the disease.