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

NCT00230997 | Completed Phase 3

• 1 other identifier: GAL-ALZ-421
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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 Lewy bodies. The primary efficacy variables will be the NPI -12, the COGDRAS tests of attention and visuospatial orientation, and the ADCS-CGIC. The secondary efficacy variables will be the MMSE, ADCS-ADL-Inventory, ADAS-Cog, PSQI, and the use of concomitant rescue antipsychotic medication. PET scanning will be obtained on 10 patients at one site. An interim analysis will also be performed. Safety outcome measures will be adverse event reports, vital signs, physical examinations, ECG, laboratory parameters and the UPDRS (motor subscale).

Conditions

Lewy Body Disease

Keywords

Galantamine; Dementia with Lewy Bodies; Treatment

Outcome Measures

Primary Outcomes (3)

• NPI-12

• ADCS-CGIC

• COGDRAS

Secondary Outcomes (5)

• ADCS-ADL

• MMSE

• ADAS-Cog

• PSQI

• Concomitant Antipsychotic Medication use

Interventions

Galantamine DRUG

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurological Research Center: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (5)

Indiana University for AD and Related Disorders

Indianapolis, Indiana, 46202, United States

Location

Buffalo Insititute for Medical Research

Buffalo, New York, 14215, United States

Location

Alzheimer's Center of Pittsburgh

Pittsburgh, Pennsylvania, 15205, United States

Location

UTHSCSA Psychiatry Department

San Antonio, Texas, 78229-3900, United States

Location

Neurological Research Center, Inc.

Bennington, Vermont, 05201, United States

Location

Related Publications (19)

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• Perry EK, Irving D, Kerwin JM, McKeith IG, Thompson P, Collerton D, Fairbairn AF, Ince PG, Morris CM, Cheng AV, et al. Cholinergic transmitter and neurotrophic activities in Lewy body dementia: similarity to Parkinson's and distinction from Alzheimer disease. Alzheimer Dis Assoc Disord. 1993 Summer;7(2):69-79. doi: 10.1097/00002093-199307020-00002.

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  PMID: 10618007 BACKGROUND

• Edwards KR, Hershey L, Wray L, Bednarczyk EM, Lichter D, Farlow M, Johnson S. Efficacy and safety of galantamine in patients with dementia with Lewy bodies: a 12-week interim analysis. Dement Geriatr Cogn Disord. 2004;17 Suppl 1:40-8. doi: 10.1159/000074681.

  PMID: 14676468 RESULT

• Edwards K, Farlow M, Hake A et al. An Open Label 24-Week, Flexible Dose Trial to Assess the Safety and Efficacy of Galantamine in Patients with Dementia with Lewy Bodies. Neurobiology of Aging. 2004; 25 (S2): 21.

  RESULT

• Edwards K, Hershey L, Farlow M, Lichter D, Johnson S: Galantamine for the treatment of dementia with Lewy bodies. Movement Disorders: S336, Vol 19/Suppl 9, 2004

  RESULT

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Keith R Edwards, M.D

  Neurological Research Center Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: October 3, 2005
• Study Start: December 1, 2002
• Study Completion: August 1, 2004
• Last Updated: December 16, 2005

Record last verified: 2005-09

Locations

US (5)