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Alzheimer's DiseasePhase 3NCT00857649

Efficacy and Safety 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 23 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 this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type. 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?
Yes, some participants may receive a placebo
How many people
369 participants
Where
23 sitesCanada
Study dates
Dec 2003to Sep 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

  • Outpatients who:
  • had a primary diagnosis of probable Alzheimer's Disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR) criteria for dementia of the Alzheimer's type
  • had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE) total score >=5 and <=15 at screening. Before substantial protocol amendment SA04 (dated 7 October 2004) was implemented, the MMSE total score range at screening was >=8 and <=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed patients who had previously had an MMSE score of 16 or 17 to be re-screened >6 months after their initial screening and, if there was documented evidence of cognitive decline, to be enrolled in the study
  • had a Neuropsychiatric Inventory (NPI) total score >=13 and an NPI agitation/aggression subitem score >=1 at screening and baseline
  • did not have vascular dementia or a modified Hachinski Ischaemia Scale score >4 at screening

Who cannot join

  • Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Canada23 sites

  • CA005

    Beauport, Quebec, G1J 2G3

  • CA032

    Burlington, Ontario, L7M 4Y1

  • CA019

    Edmonton, Alberta, T5G 0B7

  • CA023

    Greenfield Park, Quebec, J4V 2J2

  • CA033

    Kelowna, British Columbia, V1W 4V5

  • CA043

    Kelowna, V1Y 3G8

  • CA046

    Kentville, Nova Scotia, B4N 4K9

  • CA013

    Montreal, Quebec, H1T 2M4

  • CA029

    Orangeville, Ontario, L9W 2E1

  • CA004

    Ottawa, Ontario, K1N 5C8

  • CA042

    Penticton, 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

  • CA031

    Sherbrooke, Quebec, J1J 2B8

  • CA012

    Sherbrooke, Quebec, J1J 3H5

  • CA009

    Toronto, Ontario, M3B 2W7

  • CA030

    Vanier, Quebec, G1M 2R9

  • CA017

    Verdun, Quebec, H4H 1R3

  • CA037

    Windsor, Ontario, N8X 5A6

  • CA034

    Winnipeg, Manitoba, R3M 0X9

Other trials in Canada

About this study

Official title: A Randomised, Double-Blind, Parallel-Group Study Examining the Efficacy and Safety of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type

The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.

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.

This 24-week randomised, double-blind, placebo-controlled, multicentre study examines the effect of memantine 20 mg, administered once daily, on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD and significant psychopathology.

Being tested
Memantine, Placebo
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

  • PlaceboDrug

    Oral Tablets Once Daily

Study groups in NCT00857649
Study groupRoleWhat they receive
MemantineExperimentalNot described
Receives: Drug: Memantine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.

    Change from Baseline in Neuropsychiatric Inventory (NPI) total score.

    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 to Week 24

  2. Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.

    Change from Baseline in Severe Impairment Battery (SIB) total score.

    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 to Week 24

Secondary outcomes (3)

  1. Efficacy of Memantine on Global Condition Using CIBIC-plus.

    Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.

    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: Baseline to Week 24

  2. Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.

    Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.

    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 to Week 24

  3. Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.

    Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.

    CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from "1 = Never" to "7 = Several times an hour". Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances.

    Measured: Baseline to 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 startDec 2003
  3. Primary completionApr 2010
  4. Study completionSep 2010

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
Double blind
Who is masked
Participant, Investigator
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00857649
Sponsor's protocol ID
10158
Status last verified
Nov 2013
First submitted
5 Mar 2009
Last updated
5 Dec 2013
Data monitoring committee
No

Publications

  • Herrmann N, Gauthier S, Boneva N, Lemming OM; 10158 Investigators. A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease. Int Psychogeriatr. 2013 Jun;25(6):919-27. doi: 10.1017/S1041610213000239. Epub 2013 Mar 8.

    PubMed 23472619

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 23 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 5 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 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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. 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 9 Jan 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?

Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. (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 NCT00857649, which also lists 1 linked publication.

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 5 Dec 2013.

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