Status:
COMPLETED
Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies
Lead Sponsor:
Neurological Research Center
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Lewy Body Disease
Eligibility:
All Genders
51+ years
Phase:
PHASE3
Brief Summary
TRIAL SUMMARY: This is an open-label, 24-week, investigator initiated study to evaluate the safety and efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the treatment of Dementia with L...
Detailed Description
TRIAL DESIGN 1. Rationale In a previously published study of DLB treated with rivastigmine, efficacy was seen to be maximized at 20 weeks in multiple parameters compared to placebo. The efficacy ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00230997
Start Date
December 1 2002
End Date
August 1 2004
Last Update
December 16 2005
Active Locations (5)
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1
Indiana University for AD and Related Disorders
Indianapolis, Indiana, United States, 46202
2
Buffalo Insititute for Medical Research
Buffalo, New York, United States, 14215
3
Alzheimer's Center of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15205
4
UTHSCSA Psychiatry Department
San Antonio, Texas, United States, 78229-3900