Study Stopped
Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial
A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease
2 other identifiers
interventional
2,051
11 countries
88
Brief Summary
The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 19, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
September 2, 2013
CompletedSeptember 19, 2013
September 1, 2013
3.8 years
May 15, 2008
April 23, 2013
September 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Baseline, Month 24
The Number of Deaths Reported in Participants
An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.
Up to 2 years
Secondary Outcomes (7)
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Baseline, Month 6
Change From Baseline in Disability Assessment in Dementia (DAD) Scores
Baseline, Month 24
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Baseline, Months 12 and 24
Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Baseline, Months 12 and 24
Change From Baseline in Institutional Status
Baseline, Month 24
- +2 more secondary outcomes
Study Arms (2)
Galantamine
EXPERIMENTALGalantamine 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
Placebo
PLACEBO COMPARATORMatching placeco
Interventions
Eligibility Criteria
You may qualify if:
- Outpatients
- diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
- living with or have regular and frequent visits from a responsible caregiver.
You may not qualify if:
- Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
- Any of specified conditions which may contribute to dementia
- any of specified coexisting diseases, including significant cardiovascular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
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Hradec Králové, Czechia
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Mìlník 1, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
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Vorumaa, Estonia
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Limoges, France
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Bad Aibling, Germany
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Bad Homburg, Germany
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Bad Honnef, Germany
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Bamberg, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Butzbach, Germany
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Franfurt, Germany
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Fürth, Germany
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Gelsenkirchen, Germany
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Göttingen, Germany
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Hamburg, Germany
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Hanover, Germany
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Hattingen, Germany
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Karlstadt am Main, Germany
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Leverkusen, Germany
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Lüneburg, Germany
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Mittweida, Germany
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Mönchengladbach, Germany
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Nuremberg, Germany
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Oldenburg, Germany
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Ulm, Germany
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Unterhaching, Germany
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Westerstede, Germany
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Wiesbaden, Germany
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Athens, Greece
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Heraklion Crete, Greece
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Thessalonikis, Greece
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Riga, Latvia
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Kaunas, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Arad, Romania
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Bucharest, Romania
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Bucharest Sector 5, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Craiova, Romania
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Iași, Romania
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Tg Mures, Romania
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Kazan', Russia
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Kazan’, Russia
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Kirov, Russia
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Krasnodar, Russia
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Lipetsk, Russia
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Moscow, Russia
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Moscow Russia, Russia
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Nizny Novgorod, Russia
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Novosibirsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Smolensk, Russia
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Smolensk Region N/A, Russia
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Tomsk Na, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Bratislava, Slovakia
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Dubnica nad Váhom, Slovakia
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Košice, Slovakia
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Plešivec, Slovakia
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Spišská Nová Ves, Slovakia
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Šenkvice, Slovakia
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Vranov nad Topľou, Slovakia
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Kamnik, Slovenia
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Lesce, Slovenia
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Ljubljana, Slovenia
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Maribor, Slovenia
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Chernivtsy, Ukraine
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Dnipro, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Uzhhorod, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Related Publications (3)
Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PMID: 39498781DERIVEDHager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study. Alzheimers Res Ther. 2016 Nov 15;8(1):47. doi: 10.1186/s13195-016-0214-x.
PMID: 27846868DERIVEDHager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Feb 21;10:391-401. doi: 10.2147/NDT.S57909. eCollection 2014.
PMID: 24591834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 19, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
September 19, 2013
Results First Posted
September 2, 2013
Record last verified: 2013-09