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Alzheimer's DiseasePhase 3NCT00857233

Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease

A Phase 3 study testing Memantine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 33 sites in Canada.

Terminated

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

Official record
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Trial summary

The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Memantine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
33 sitesCanada
Study dates
Jun 2004to Oct 2010
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who have completed the 24-week Study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.

Who cannot join

  • Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Canada33 sites

  • CA005

    Beauport, Quebec, G1J 2G3

  • CA032

    Burlington, Ontario, L7M 4Y1

  • CA044

    Chatham, N7L 1B7

  • CA019

    Edmonton, Alberta, T5G 0B7

  • CA023

    Greenfield Park, Quebec, J4V 2J2

  • CA033

    Kelowna, British Columbia, V1W 4V5

  • CA043

    Kelowna, British Columbia, V1Y 3G8

  • CA007

    Kentville, B4N 4K9

  • CA046

    Kentville, B4N 4K9

  • CA001

    Kingston, K7L 2V7

  • CA003

    London, N6A 4V2

  • CA002

    London, N6C5J1

  • CA016

    Moncton, E1C 4B7

  • CA013

    Montreal, Quebec, H1T 2M4

  • CA024

    Montreal, H2X 3J4

  • CA014

    Montreal, H3T 1E2

  • CA011

    Montreal, H4H 1R3

  • CA029

    Orangeville, Ontario, L9W 2E1

  • CA004

    Ottawa, Ontario, K1N 5C8

  • CA042

    Penticton, British Columbia, V2A 5C8

  • CA038

    Peterborough, Ontario, K9H 2P4

  • CA045

    Pictou, Nova Scotia, B0K 1H0

  • CA015

    Regina, Saskatchewan, S4T 1A5

  • CA022

    Saint John, New Brunswick

  • CA040

    Saskatoon, Saskatchewan, S7N 0W8

  • CA012

    Sherbrooke, Quebec, J1J 3H5

  • CA031

    Sherbrooke, J1J 2B8

  • CA009

    Toronto, Ontario, M3B 2W7

  • CA006

    Toronto, M6M 3Z5

  • CA030

    Vanier, Quebec, G1M 2R9

  • CA017

    Verdun, Quebec, H4H 1R3

  • CA037

    Windsor, N8X 5A6

  • CA034

    Winnipeg, Manitoba, R3M 0X9

Other trials in Canada

About this study

Official title: An Open-label Extension Study Examining the Safety and Tolerability of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type Having Completed Study 10158

The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.

Read the detailed description

Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158.

In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Being tested
Memantine
Keywords
Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

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

  • MemantineDrug

    Also called Ebixa®

    20 mg oral tablets once daily

Study groups in NCT00857233
Study groupRoleWhat they receive
MemantineExperimentalNot described
Receives: Drug: Memantine

What is being measured

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

  1. Number of Patients With Adverse Events (AEs)

    Overview of AEs

    Measured: Baseline to Week 24

  2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment

    Measured: Baseline to Week 24

Secondary outcomes (4)

  1. Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.

    Change from Baseline in the NPI total score. Analysed by descriptive methods only.

    NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances.

    Measured: Baseline and Week 24

  2. Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.

    Change from Baseline in the SIB total score. Analysed by descriptive methods only.

    SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function.

    Measured: Baseline and Week 24

  3. Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).

    CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.

    CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.

    Measured: Week 24

  4. Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score

    Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.

    ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment.

    Measured: Baseline and Week 24

Timeline

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

  1. First posted6 Mar 2009 (estimated)
  2. Study startJun 2004
  3. Primary completionJul 2010
  4. Study completionOct 2010

Why it stopped: Please see explanation in the Detailed Description field.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00857233
Sponsor's protocol ID
10252
Status last verified
Jul 2012
First submitted
5 Mar 2009
Last updated
29 Aug 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Memantine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 33 sites in Canada.

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 1 inclusion and 1 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 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Canada. 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. 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 29 Aug 2012). 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?

Number of Patients With Adverse Events (AEs) (time frame: Baseline to Week 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 NCT00857233.

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 29 Aug 2012.

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