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

September 10, 2013 updated by: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2051

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic
      • Mìlník 1, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava, Czech Republic
      • Ostrava 3, Czech Republic
      • Praha 2, Czech Republic
      • Praha 8, Czech Republic
  • Estonia
      • Tallinn, Estonia
      • Tallinn N/A, Estonia
      • Tartu, Estonia
      • Viljandi N/A, Estonia
      • Vorumaa, Estonia
  • France
      • Limoges, France
  • Germany
      • 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
      • Hannover, Germany
      • Hattingen, Germany
      • Karlstadt, Germany
      • Leverkusen, Germany
      • Lüneburg, Germany
      • Mittweida, Germany
      • Mönchengladbach, Germany
      • Nürnberg, Germany
      • Oldenburg, Germany
      • Ulm, Germany
      • Unterhaching, Germany
      • Westerstede, Germany
      • Wiesbaden, Germany
  • Greece
      • Athens, Greece
      • Heraklion Crete, Greece
      • Thessalonikis, Greece
  • Latvia
      • Riga, Latvia
  • Lithuania
      • Kaunas, Lithuania
      • Siauliai, Lithuania
      • Vilnius, Lithuania
  • Romania
      • Arad, Romania
      • Bucharest, Romania
      • Bucharest Sector 5, Romania
      • Cluj-Napoca, Romania
      • Constanta, Romania
      • Craiova, Romania
      • Iasi, Romania
      • Tg Mures, Romania
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Kazan, Russian Federation
      • Kazan N/A, Russian Federation
      • Kirov, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnodar N/A, Russian Federation
      • Lipetsk, Russian Federation
      • Moscow, Russian Federation
      • Moscow Russia, Russian Federation
      • Nizny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • Smolensk Region N/A, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • St.Petersburg, Russian Federation
      • Tomsk Na, Russian Federation
      • Voronezh, Russian Federation
      • Yaroslavl, Russian Federation
  • Slovakia
      • Bratislava, Slovakia
      • Dubnica Nad Vahom, Slovakia
      • Kosice, Slovakia
      • Plesivec, Slovakia
      • Senkvice, Slovakia
      • Spisska Nova Ves, Slovakia
      • Vranov Nad Toplou, Slovakia
  • Slovenia
      • Kamnik, Slovenia
      • Lesce, Slovenia
      • Ljubljana, Slovenia
      • Maribor, Slovenia
  • Ukraine
      • Chernivtsy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Dnipropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kharkov, Ukraine
      • Kherson, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Lvov, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Simferopol, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Galantamine
Galantamine 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
Drug: Galantamine
8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
Placebo Comparator: Placebo
Matching placeco
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline, Month 24
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
Time Frame: Up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline, Month 6
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 6
Change From Baseline in Disability Assessment in Dementia (DAD) Scores
Time Frame: Baseline, Month 24
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Baseline, Month 24
Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)
Time Frame: Baseline, Months 12 and 24
The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants "home with friend or relative" using the 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)
Time Frame: Baseline, Months 12 and 24
The table below presents the number of days that caregiving activities were provided during the past week.
Baseline, Months 12 and 24
Change From Baseline in Institutional Status
Time Frame: Baseline, Month 24
This table describes the number of participants who were reported as institutionalized at baseline and Month 24.
Baseline, Month 24
Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)
Time Frame: Baseline, Month 24
The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.
Baseline, Month 24
Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)
Time Frame: Baseline, Month 24
The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.
Baseline, Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012463
  • GALALZ3005 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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