- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00253214
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
19. mai 2011 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety and effectiveness of a once daily controlled-release form of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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 the ability to perform daily tasks related to personal care (for example, bathing, dressing, and eating) and may be unable to handle money or travel to familiar places.
Previous clinical trials have shown that a twice-daily dose of galantamine (18 - 32 mg/day) improved symptoms of Alzheimer's disease.
This multicenter, double-blind, placebo-controlled study evaluates the safety and effectiveness of a controlled-release form of galantamine in patients with Alzheimer's disease.
All patients receive placebo during the first month of the study.
Patients then receive controlled-release galantamine (8 - 24 mg once daily), or immediate-release galantamine (4 - 12 mg twice daily) or placebo for 6 months.
The dose of galantamine starts at 8 mg/day and may be increased up to 24 mg/day, if needed.
The dose may be adjusted up or down during the first 12 weeks of double-blind treatment based upon effectiveness and tolerability.
Patients continue to receive the dose they are taking at the end of 12 weeks for the remainder of the study.
The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores.
Additional measures of effectiveness include the change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and the Neuropsychiatric Inventory (NPI) scores.
Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) are performed throughout the study.
Patients who complete the double-blind portion of the study have the opportunity to receive galantamine in an open-label follow-up study.
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 treatment with controlled-release galantamine is effective in improving the symptoms of Alzheimer's disease and is well tolerated.
Controlled-release galantamine 8 - 24 mg by mouth once daily, or immediate-release galantamine 4 - 12 mg by mouth twice daily, or placebo.
Dosing starts at 8 mg/day and may be increased up to 24 mg/day, if needed.
The study duration is 6 months.
Studietype
Intervensjonell
Registrering (Faktiske)
973
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Outpatients with a diagnosis of mild-to-moderate 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 in residential homes for the elderly or day patients)
- have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least 18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11) with an onset between ages 40 and 90
- 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
- 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
- dementia caused by small strokes or cerebrovascular disease
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Change from baseline to end of treatment for controlled release group in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
|
Sekundære resultatmål
Resultatmål |
---|
Change from baseline in ADAS-cog/13, /10, /mem scores, NPI, and ADCS/ADL; safety and tolerability of controlled-release formulation; difference in effects between the controlled-release and immediate-release formulations
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2001
Studiet fullført (Faktiske)
1. juli 2002
Datoer for studieregistrering
Først innsendt
10. november 2005
Først innsendt som oppfylte QC-kriteriene
10. november 2005
Først lagt ut (Anslag)
15. november 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. mai 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2011
Sist bekreftet
1. november 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevrokognitive lidelser
- Nevrodegenerative sykdommer
- Tauopatier
- Demens
- Alzheimers sykdom
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Enzymhemmere
- Nootropiske midler
- Kolinesterasehemmere
- Parasympathomimetika
- Galantamin
Andre studie-ID-numre
- CR006037
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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