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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230997
First Posted: October 3, 2005
Last Update Posted: December 16, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Neurological Research Center
  Purpose

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).


Condition Intervention Phase
Lewy Body Disease Drug: Galantamine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label 24-Week, Flexible Dose Trial to Assess the Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies

Resource links provided by NLM:


Further study details as provided by Neurological Research Center:

Primary Outcome Measures:
  • NPI-12
  • ADCS-CGIC
  • COGDRAS

Secondary Outcome Measures:
  • ADCS-ADL
  • MMSE
  • ADAS-Cog
  • PSQI
  • Concomitant Antipsychotic Medication use

Estimated Enrollment: 50
Study Start Date: December 2002
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230997


Locations
United States, Indiana
Indiana University for AD and Related Disorders
Indianapolis, Indiana, United States, 46202
United States, New York
Buffalo Insititute for Medical Research
Buffalo, New York, United States, 14215
United States, Pennsylvania
Alzheimer's Center of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15205
United States, Texas
UTHSCSA Psychiatry Department
San Antonio, Texas, United States, 78229-3900
United States, Vermont
Neurological Research Center, Inc.
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Neurological Research Center
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Keith R Edwards, M.D Neurological Research Center Inc.
  More Information

Publications:
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.
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.
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
Tonkopii, V.D., Prozorovskii, V.B. and Suslova, I.M. Interaction of reversible inhibition with catalytic centers and allosteric site of cholinesterases. Bull. Exp. Bio. Med., 82:1180-1183, 1976
Thomsen T, Kewitz H. Selective inhibition of human acetylcholinesterase by galanthamine in vitro and in vivo. Life Sci. 1990;46(21):1553-8.
Maelicke A, Albuquerque EX. Allosteric modulation of nicotinic acetylcholine receptors as a treatment strategy for Alzheimer's disease. Eur J Pharmacol. 2000 Mar 30;393(1-3):165-70.
Papka M, Rubio A, Schiffer RB. A review of Lewy body disease, an emerging concept of cortical dementia. J Neuropsychiatry Clin Neurosci. 1998 Summer;10(3):267-79. Review.
Hansen L, Salmon D, Galasko D, Masliah E, Katzman R, DeTeresa R, Thal L, Pay MM, Hofstetter R, Klauber M, et al. The Lewy body variant of Alzheimer's disease: a clinical and pathologic entity. Neurology. 1990 Jan;40(1):1-8.
Perry RH, Irving D, Blessed G, Fairbairn A, Perry EK. Senile dementia of Lewy body type. A clinically and neuropathologically distinct form of Lewy body dementia in the elderly. J Neurol Sci. 1990 Feb;95(2):119-39.
Holmes C, Cairns N, Lantos P, Mann A. Validity of current clinical criteria for Alzheimer's disease, vascular dementia and dementia with Lewy bodies. Br J Psychiatry. 1999 Jan;174:45-50.
McKeith IG, Galasko D, Kosaka K, Perry EK, Dickson DW, Hansen LA, Salmon DP, Lowe J, Mirra SS, Byrne EJ, Lennox G, Quinn NP, Edwardson JA, Ince PG, Bergeron C, Burns A, Miller BL, Lovestone S, Collerton D, Jansen EN, Ballard C, de Vos RA, Wilcock GK, Jellinger KA, Perry RH. Consensus guidelines for the clinical and pathologic diagnosis of dementia with Lewy bodies (DLB): report of the consortium on DLB international workshop. Neurology. 1996 Nov;47(5):1113-24. Review.
McKeith IG, Ballard CG, Perry RH, Ince PG, O'Brien JT, Neill D, Lowery K, Jaros E, Barber R, Thompson P, Swann A, Fairbairn AF, Perry EK. Prospective validation of consensus criteria for the diagnosis of dementia with Lewy bodies. Neurology. 2000 Mar 14;54(5):1050-8.
Perry EK, Marshall E, Perry RH, Irving D, Smith CJ, Blessed G, Fairbairn AF. Cholinergic and dopaminergic activities in senile dementia of Lewy body type. Alzheimer Dis Assoc Disord. 1990 Summer;4(2):87-95.
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.
Shiozaki K, Iseki E, Uchiyama H, Watanabe Y, Haga T, Kameyama K, Ikeda T, Yamamoto T, Kosaka K. Alterations of muscarinic acetylcholine receptor subtypes in diffuse lewy body disease: relation to Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):209-13.
McKeith IG, Grace JB, Walker Z, Byrne EJ, Wilkinson D, Stevens T, Perry EK. Rivastigmine in the treatment of dementia with Lewy bodies: preliminary findings from an open trial. Int J Geriatr Psychiatry. 2000 May;15(5):387-92.
McKeith I, Del Ser T, Spano P, Emre M, Wesnes K, Anand R, Cicin-Sain A, Ferrara R, Spiegel R. Efficacy of rivastigmine in dementia with Lewy bodies: a randomised, double-blind, placebo-controlled international study. Lancet. 2000 Dec 16;356(9247):2031-6.
Shea C, MacKnight C, Rockwood K. Donepezil for treatment of dementia with Lewy bodies: a case series of nine patients. Int Psychogeriatr. 1998 Sep;10(3):229-38.
Cummings JL. Cholinesterase inhibitors: A new class of psychotropic compounds. Am J Psychiatry. 2000 Jan;157(1):4-15. Review.

ClinicalTrials.gov Identifier: NCT00230997     History of Changes
Other Study ID Numbers: GAL-ALZ-421
First Submitted: September 29, 2005
First Posted: October 3, 2005
Last Update Posted: December 16, 2005
Last Verified: September 2005

Keywords provided by Neurological Research Center:
Galantamine
Dementia with Lewy Bodies
Treatment

Additional relevant MeSH terms:
Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents


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