A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease

NCT ID: NCT00679627

Last Updated: 2013-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2051 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-05-31

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).

Detailed Description

This is a long-term (2-year), randomized (patients will be assigned to treatment by chance), double blind (neither the physician nor the patient will know which treatment is assigned) study of galantamine versus placebo in subjects with mild to moderately-severe AD. Approximately 2,000 patients will participate in this study. The study length for each patient is approximately 25.5 months. The study consists of 3 phases: a pretreatment phase, a treatment phase, and a posttreatment phase. The pretreatment phase includes a 2-week screening period (to obtain a patient's and his or her caregiver's informed consent and to confirm eligibility for the study) and a baseline visit at which subjects will be randomly assigned, in a 1 to 1 ratio, to receive either galantamine or placebo once a day in the morning. Study drug will first be dispensed at the baseline visit. The treatment phase is composed of a titration period (the study drug will be introduced gradually) and a maintenance period and includes 9 visits (3 of which are conducted by telephone). The titration period is 12 weeks long, and visits occur about every 28 days. In the first 4 weeks of the titration period, subjects will receive either 8 mg galantamine or matching placebo, and this dose will be increased to 16 mg galantamine or placebo in the second 4 weeks. The dose will then be increased to 24 mg galantamine or placebo for the final 4 weeks of the titration period if the investigator believes the subject will benefit from and will safely tolerate 24 mg/day. If not, the subject may continue to receive 16 mg galantamine or placebo through the end of the titration period. After the titration period, subjects will enter the maintenance period and continue to take study drug at the dosage they received at the end of the titration period. This dosage may be continued through the end of the study or may be changed once (either up from 16 to 24 mg or down from 24 to 16 mg), depending upon the benefit and the safety of such a change for the individual patient as judged by the investigator. No dosage will exceed 24 mg/day. The posttreatment phase includes an End-of-Study Visit that occurs at the end of the maintenance period. A follow-up telephone contact (interview) is conducted 1 month after the End-of-Study Visit. The effectiveness of galantamine will be evaluated using the following tools: the Mini-Mental State Examination (MMSE); the Disability Assessment in Dementia (DAD); and the Assessment of Patient Accommodation Status and Caregiver Burden (APAS CarB). Safety evaluations for the study include the monitoring of vital status and institutionalization status, adverse events, vital signs, weight, physical and neurologic examinations. A Data Safety Monitoring Board, external to the company, has been commissioned for this study to monitor the progress of the study and to ensure that the safety of patients is not compromised. The effectiveness hypothesis of this study is that galantamine, 16 to 24 mg per day, is superior to placebo in reducing cognitive decline from baseline (start of study drug) as measured by the MMSE over the course of 2 years. The safety hypothesis is that the mortality rate in the galantamine 16 to 24 mg per day treatment group will be the same as that in the placebo group over the course of 2 years.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Galantamine; Dementia, Alzheimer type; Memory loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Galantamine

Galantamine 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day

Group Type: EXPERIMENTAL

Galantamine

Intervention Type: DRUG

8mg/ day oral capsule increased to 16mg/day then to 24 mg per day

Placebo

Matching placeco

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

Galantamine

8mg/ day oral capsule increased to 16mg/day then to 24 mg per day

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Hradec Králové, , Czechia

Mìlník 1, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Prague, , Czechia

Tallinn, , Estonia

Tartu, , Estonia

Viljandi, , Estonia

Vorumaa, , Estonia

Limoges, , France

Bad Aibling, , Germany

Bad Homburg, , Germany

Bad Honnef, , Germany

Bamberg, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bochum, , Germany

Butzbach, , Germany

Franfurt, , Germany

Fürth, , Germany

Gelsenkirchen, , Germany

Göttingen, , Germany

Hamburg, , Germany

Hanover, , Germany

Hattingen, , Germany

Karlstadt am Main, , Germany

Leverkusen, , Germany

Lüneburg, , Germany

Mittweida, , Germany

Mönchengladbach, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Ulm, , Germany

Unterhaching, , Germany

Westerstede, , Germany

Wiesbaden, , Germany

Athens, , Greece

Heraklion Crete, , Greece

Thessalonikis, , Greece

Riga, , Latvia

Kaunas, , Lithuania

Šiauliai, , Lithuania

Vilnius, , Lithuania

Arad, , Romania

Bucharest, , Romania

Bucharest Sector 5, , Romania

Cluj-Napoca, , Romania

Constanța, , Romania

Craiova, , Romania

Iași, , Romania

Tg Mures, , Romania

Kazan', , Russia

Kazan’, , Russia

Kirov, , Russia

Krasnodar, , Russia

Lipetsk, , Russia

Moscow, , Russia

Moscow Russia, , Russia

Nizny Novgorod, , Russia

Novosibirsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Saratov, , Russia

Smolensk, , Russia

Smolensk Region N/A, , Russia

Tomsk Na, , Russia

Voronezh, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Bratislava, , Slovakia

Dubnica nad Váhom, , Slovakia

Košice, , Slovakia

Plešivec, , Slovakia

Spišská Nová Ves, , Slovakia

Šenkvice, , Slovakia

Vranov nad Topľou, , Slovakia

Kamnik, , Slovenia

Lesce, , Slovenia

Ljubljana, , Slovenia

Maribor, , Slovenia

Chernivtsy, , Ukraine

Dnipro, , Ukraine

Dnipropetrovsk, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kherson, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Simferopol, , Ukraine

Uzhhorod, , Ukraine

Vinnitsa, , Ukraine

Countries

Austria; Belgium; Cyprus; Malta; Netherlands; Norway; Portugal; Spain; United Kingdom; Czechia; Estonia; France; Germany; Greece; Latvia; Lithuania; Romania; Russia; Slovakia; Slovenia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 39498781 (View on PubMed)

Hager 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.

Reference Type: DERIVED

PMID: 27846868 (View on PubMed)

Hager 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.

Reference Type: DERIVED

PMID: 24591834 (View on PubMed)

Other Identifiers

GALALZ3005

Identifier Type: OTHER

Identifier Source: secondary_id

CR012463

Identifier Type: -

Identifier Source: org_study_id