- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00253188
A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease
17. maj 2011 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Efficacy, Tolerability and Safety of Galantamine in the Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and effectiveness of two doses of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought.
The most common type of dementia is Alzheimer's disease.
Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places.
Several small clinical trials have shown galantamine to be safe and effective in treating the symptoms associated with Alzheimer's disease.
Doses studied have ranged from 15 - 60 mg/day, with galantamine administered two or three times daily.
Additional information is needed to determine the optimal dose regimen for galantamine in the treatment of Alzheimer's' disease.
This multicenter, double-blind, placebo-controlled (neither the patient nor the study doctor know the dose of galantamine being given) study evaluates the safety and effectiveness of two doses of galantamine, each given twice daily, in the treatment of patients with Alzheimer's disease.
All patients initially receive placebo for a 1-month period and then receive one of two doses of galantamine (beginning at 4 mg twice daily and gradually increasing to 12 or 16 mg twice daily) or placebo for 6 months.
The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input).
Additional measures of effectiveness assessed at the end of the treatment include the ADAS-cog/13 score (Alzheimer's Disease Assessment Scale: sum of 13 cognitive items) and the Disability Assessment for Dementia (DAD) score.
Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) are performed throughout the study.
Caregiver quality of life (Psychological General Well Being Index, [PGWB]) and health/social care resource utilization (physician and other health care professional visits, use of social services, etc.) are also assessed throughout the study by questionnaires answered by the caregivers.
Blood samples are taken throughout the study to determine the concentration of drug in the blood.
Patients may also participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies.
The study hypothesis is that galantamine administered in either dose is effective in the treatment of Alzheimer's disease as compared with placebo, and is well tolerated.
This study will be conducted internationally.
A companion study of exact design will be conducted in the United States.
Galantamine tablets (or placebo), taken orally twice daily for 6 months beginning with 4 mg twice daily and gradually increasing to 12 or 16 mg twice daily.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
653
Fase
- Fase 3
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients)
- have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination (MMSE) score of 11 - 24 and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog)
- history of at least a 6 months of gradual and progressive cognitive decline
- have a consistent informant to accompany the patient on scheduled visits
Exclusion Criteria:
- Neurogenerative disorders such as Parkinson's disease
- dementia caused by small strokes or cerebrovascular disease
- cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation or a brain tumor
- having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney, or lung disorders, or heart disease
- Females of child bearing potential without adequate contraception
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Ændring fra baseline til slutningen af behandlingen i ADAS-cog/11 (Alzheimers Disease Assessment Scale: sum af 11 kognitive elementer) og CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
|
Sekundære resultatmål
Resultatmål |
---|
Change from baseline in ADAS-cog/13 and DAD scores to the end of treatment; concentration of drug in blood; PGWB; Health/social care resource use; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group. BMJ. 2000 Dec 9;321(7274):1445-9. doi: 10.1136/bmj.321.7274.1445. Erratum In: BMJ 2001 Feb 17;322(7283):405.
- Pirttila T, Wilcock G, Truyen L, Damaraju CV. Long-term efficacy and safety of galantamine in patients with mild-to-moderate Alzheimer's disease: multicenter trial. Eur J Neurol. 2004 Nov;11(11):734-41. doi: 10.1111/j.1468-1331.2004.00885.x.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 1997
Studieafslutning (Faktiske)
1. december 1998
Datoer for studieregistrering
Først indsendt
10. november 2005
Først indsendt, der opfyldte QC-kriterier
10. november 2005
Først opslået (Skøn)
15. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. maj 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2011
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurokognitive lidelser
- Neurodegenerative sygdomme
- Tauopatier
- Demens
- Alzheimers sygdom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Enzymhæmmere
- Nootropiske midler
- Cholinesterasehæmmere
- Parasympathomimetika
- Galantamin
Andre undersøgelses-id-numre
- CR006031
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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