Alzheimer's DiseasePhase 2NCT00884507
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing RO5313534 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 67 sites in 13 countries.
Trial summary
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background… 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?
- RO5313534
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 389 participants
- Where
- 67 sitesin 13 countries
- Study dates
- May 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- adult patients, >/=50 years of age;
- probable Alzheimer's disease;
- MMSE score at screening of 13-22;
- under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;
- not requiring nursing home care, but looked after by a caregiver/carer.
Who cannot join
- dementia due to condition other than Alzheimer's disease;
- other significant neurological disorder;
- untreated/non-stabilized major depressive disorder;
- bipolar disorder, schizophrenia, or any other serious psychiatric condition.
Trial locations and contacts
67 sites in 13 countries.
67 sites in 13 countries
United States15 sites
Study site
Albuquerque, New Mexico, 87109
Study site
Creve Coeur, Missouri, 63141
Study site
Delray Beach, Florida, 33445
Study site
Eatontown, New Jersey, 07724
Study site
Fort Myers, Florida, 33912
Study site
Kalamazoo, Michigan, 49048
Study site
Maitland, Florida, 32751
Study site
Norwalk, Connecticut, 06851
Study site
Orange, California, 92868
Study site
Paducah, Kentucky, 42003
Study site
Portland, Oregon, 97210
Study site
Tampa, Florida, 33613-4706
Study site
Tampa, Florida, 33613
Study site
Torrance, California, 90502
Study site
White Plains, New York, 10605
Canada11 sites
Study site
Kingston, Ontario, K7L 5G2
Study site
London, Ontario, N6C 5J1
Study site
Medicine Hat, Alberta, T1A-4C2
Study site
Montreal, Quebec, H3T 1E2
Study site
Ottawa, Ontario, K1N 5C8
Study site
Peterborough, Ontario, K9H 2P4
Study site
Regina, Saskatchewan, S4T 7T1
Study site
Toronto, Ontario, M3B 2S7
Study site
Toronto, Ontario, M4N 3M5
Study site
Vancouver, British Columbia, V6T 2B5
Study site
Verdun, Quebec, H4H 1R3
Spain6 sites
Study site
Barakaldo, Vizcaya, 48903
Study site
BArcelon, Barcelona, 08034
Study site
Barcelona, Barcelona, 08003
Study site
Madrid, Madrid, 28034
Study site
Málaga, Malaga, 29010
Study site
Salt, Girona, 17090
Argentina4 sites
Study site
Buenos Aires, C1090AAH
Study site
Buenos Aires, C1425AGC
Study site
Buenos Aires, C1431FWO
Study site
Caba, C1126AAB
France4 sites
Study site
Montpellier, 34295
Study site
Nice, 06003
Study site
Saint-Herblain, 44800
Study site
Toulouse, 31059
Germany4 sites
Study site
Günzburg, 89312
Study site
Leipzig, 04107
Study site
München, 80331
Study site
Nuremberg, 90402
Italy4 sites
Study site
Castellanza, Lombardy, 21053
Study site
Milan, Lombardy, 20122
Study site
Milan, Lombardy, 20132
Study site
Naples, Campania, 80131
Mexico4 sites
Study site
Aguascalientes, 20127
Study site
Guadalajara, 44610
Study site
Monterrey, 64460
Study site
Saltillo, 25000
Poland4 sites
Study site
Gdansk, 80-282
Study site
Leszno, 64-100
Study site
Torun, 87-100
Study site
Warsaw, 02-097
United Kingdom4 sites
Study site
Blackpool, FY20JH
Study site
Bradford, BD30DQ
Study site
Glasgow, G20 0XA
Study site
Southampton, SO30 3JB
Australia3 sites
Study site
Chermside, Queensland, 4032
Study site
Hornsby, New South Wales, 2077
Study site
Woodville, South Australia, 5011
About this study
Official title: A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.
- Conditions
- Alzheimer's Disease
- Being tested
- Placebo, RO5313534
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po daily for 24 weeks
RO5313534Drug
1mg po daily for 24 weeks
RO5313534Drug
5mg po daily for 24 weeks
RO5313534Drug
15mg po daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RO5313534 15mg | Experimental | Not described Receives: Drug: RO5313534 |
| RO5313534 1mg | Experimental | Not described Receives: Drug: RO5313534 |
| RO5313534 5mg | Experimental | Not described Receives: Drug: RO5313534 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Measured: Week 24
Secondary outcomes (2)
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Measured: At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Measured: At intervals to week 24, then at week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884507
- Sponsor's protocol ID
- WN22018
- Other IDs
- 2008-004012-13, 2008
- Status last verified
- Nov 2016
- First submitted
- 17 Apr 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00884507
- Acronym / sponsor ID
- WN22018
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| RO5313534 15mg | Experimental | Drug: RO5313534 |
| RO5313534 1mg | Experimental | Drug: RO5313534 |
| RO5313534 5mg | Experimental | Drug: RO5313534 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >/=50 years of age;
- probable Alzheimer's disease;
- MMSE score at screening of 13-22;
- under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;
- not requiring nursing home care, but looked after by a caregiver/carer.
Key exclusion criteria (4 listed)
- dementia due to condition other than Alzheimer's disease;
- other significant neurological disorder;
- untreated/non-stabilized major depressive disorder;
- bipolar disorder, schizophrenia, or any other serious psychiatric condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebopo daily for 24 weeks | Drug | Placebo |
| RO53135341mg po daily for 24 weeks | Drug | RO5313534 1mg |
| RO53135345mg po daily for 24 weeks | Drug | RO5313534 5mg |
| RO531353415mg po daily for 24 weeks | Drug | RO5313534 15mg |
Primary outcome
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time frame: Week 24
2 secondary outcomes
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Time frame: At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Time frame: At intervals to week 24, then at week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
67 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5313534 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 67 sites in 13 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, Spain, Argentina, France and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.