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Alzheimer's DiseasePhase 3NCT00679627

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

A Phase 3 study testing Galantamine in people with Alzheimer's Disease, run by Janssen Research & Development, LLC at 95 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Galantamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,051 participants
Where
95 sitesin 12 countries
Study dates
Jun 2008to May 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

Germany26 sites

  • Study site

    Bad Aibling

  • Study site

    Bad Homburg

  • Study site

    Bad Honnef

  • Study site

    Bamberg

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Bochum

  • Study site

    Butzbach

  • Study site

    Franfurt

  • Study site

    Fürth

  • Study site

    Gelsenkirchen

  • Study site

    Göttingen

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Hattingen

  • Study site

    Karlstadt am Main

  • Study site

    Leverkusen

  • Study site

    Lüneburg

  • Study site

    Mittweida

  • Study site

    Mönchengladbach

  • Study site

    Nuremberg

  • Study site

    Oldenburg

  • Study site

    Ulm

  • Study site

    Unterhaching

  • Study site

    Westerstede

  • Study site

    Wiesbaden

Other trials in Germany

Russia19 sites

  • Study site

    Kazan'

  • Study site

    Kazan’

  • Study site

    Kirov

  • Study site

    Krasnodar

  • Study site

    Lipetsk

  • Study site

    Moscow

  • Study site

    Moscow Russia

  • Study site

    Nizny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Smolensk Region N/A

  • Study site

    Tomsk Na

  • Study site

    Voronezh

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

Ukraine14 sites

  • Study site

    Chernivtsy

  • Study site

    Dnipro

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kherson

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Simferopol

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

Other trials in Ukraine

Romania8 sites

  • Study site

    Arad

  • Study site

    Bucharest

  • Study site

    Bucharest Sector 5

  • Study site

    Cluj-Napoca

  • Study site

    Constanța

  • Study site

    Craiova

  • Study site

    Iași

  • Study site

    Tg Mures

Other trials in Romania

Slovakia7 sites

  • Study site

    Bratislava

  • Study site

    Dubnica nad Váhom

  • Study site

    Košice

  • Study site

    Plešivec

  • Study site

    Šenkvice

  • Study site

    Spišská Nová Ves

  • Study site

    Vranov nad Topľou

Other trials in Slovakia

Czechia5 sites

  • Study site

    Hradec Králové

  • Study site

    Mìlník 1

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Prague

Other trials in Czechia

Estonia4 sites

  • Study site

    Tallinn

  • Study site

    Tartu

  • Study site

    Viljandi

  • Study site

    Vorumaa

Other trials in Estonia

Slovenia4 sites

  • Study site

    Kamnik

  • Study site

    Lesce

  • Study site

    Ljubljana

  • Study site

    Maribor

Other trials in Slovenia

Greece3 sites

  • Study site

    Athens

  • Study site

    Heraklion Crete

  • Study site

    Thessalonikis

Other trials in Greece

Lithuania3 sites

  • Study site

    Kaunas

  • Study site

    Šiauliai

  • Study site

    Vilnius

Other trials in Lithuania

France1 site

  • Study site

    Limoges

Other trials in France

Latvia1 site

  • Study site

    Riga

Other trials in Latvia

About this study

Official title: 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).

Read the 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.

Being tested
Galantamine, Placebo
Keywords
Alzheimer's Disease, Galantamine, Dementia, Alzheimer type, Memory loss
Medical subject headings
Alzheimer Disease, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalantamineDrug

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

  • PlaceboDrug

    Matching placebo

Study groups in NCT00679627
Study groupRoleWhat they receive
GalantamineExperimentalGalantamine 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
Receives: Drug: Galantamine
PlaceboPlacebo comparatorMatching placeco
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Month 24

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, Month 6

  2. Change From Baseline in Disability Assessment in Dementia (DAD) Scores

    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.

    Measured: Baseline, Month 24

  3. Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

    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.

    Measured: Baseline, Months 12 and 24

  4. Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

    The table below presents the number of days that caregiving activities were provided during the past week.

    Measured: Baseline, Months 12 and 24

  5. Change From Baseline in Institutional Status

    This table describes the number of participants who were reported as institutionalized at baseline and Month 24.

    Measured: Baseline, Month 24

  6. Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)

    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.

    Measured: Baseline, Month 24

  7. Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)

    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.

    Measured: Baseline, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2012
  4. Study completionMay 2012

Why it stopped: Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,051 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679627
Sponsor's protocol ID
CR012463
Other IDs
GALALZ3005
Status last verified
Sep 2013
First submitted
15 May 2008
Last updated
19 Sep 2013

Publications

  • 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.

    PubMed 39498781

  • 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.

    PubMed 27846868

  • 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.

    PubMed 24591834

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galantamine in people with Alzheimer's Disease, run by Janssen Research & Development, LLC at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in Germany, Russia, Ukraine, Romania, Slovakia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Mini-Mental State Examination (MMSE) Score (time frame: Baseline, Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679627, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.

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