Dementia Alzheimer's TypePhase 2NCT01266525
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
A Phase 2 study testing SAR110894 and Donepezil in people with Dementia Alzheimer's Type, run by Sanofi at 82 sites in 9 countries.
Trial summary
Primary Objective: To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy Secondary Objectives: To explore the effect of SAR110894 on functional… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia Alzheimer's Type
- What is being tested?
- SAR110894 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 82 sitesin 9 countries
- Study dates
- Feb 2011to Jan 2013
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).
- Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit.
Who cannot join
- Age <55 years old.
- Psychotic features, agitation, or behavioral problems within the last 3 months.
- Patients unable to comply with ophthalmologic monitoring.
- Lack of consistent and reliable caregiver.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
82 sites in 9 countries.
82 sites in 9 countries
United States27 sites
Investigational Site Number 840038
Austin, Texas, 78757
Investigational Site Number 840008
Baton Rouge, Louisiana, 70808
Investigational Site Number 840021
Bennington, Vermont, 05201
Investigational Site Number 840018
Cedarhurst, New York, 11516
Investigational Site Number 840039
Charlotte, North Carolina, 28204
Investigational Site Number 840024
Costa Mesa, California, 92626
Investigational Site Number 840034
Darien, Connecticut, 06820
Investigational Site Number 840003
Delray Beach, Florida, 33445
Investigational Site Number 840040
Eatontown, New Jersey, 07724
Investigational Site Number 840014
Franklin, Tennessee, 37067
Investigational Site Number 840013
Fresno, California, 93720
Investigational Site Number 840041
Gilbert, Arizona, 85234
Investigational Site Number 840009
Hattiesburg, Mississippi, 39401
Investigational Site Number 840015
Hialeah, Florida, 33016
Investigational Site Number 840004
Jacksonville, Florida, 32216
Investigational Site Number 840030
La Jolla, California, 92037
Investigational Site Number 840006
Miami, Florida, 33155
Investigational Site Number 840012
Orlando, Florida, 32806
Investigational Site Number 840032
Phoenix, Arizona, 85060
Investigational Site Number 840025
Quincy, Massachusetts, 02169
Investigational Site Number 840001
Redlands, California, 92374
Investigational Site Number 840002
Santa Ana, California, 92705
Investigational Site Number 840026
Sherman Oaks, California, 91403
Investigational Site Number 840011
Tampa, Florida, 33609-4052
Investigational Site Number 840037
Tulsa, Oklahoma, 74104
Investigational Site Number 840005
West Palm Beach, Florida, 33407
Investigational Site Number 840031
Williamsburg, Virginia, 23185
Canada12 sites
Investigational Site Number 124010
Calgary, T2N 2T9
Investigational Site Number 124015
Gatineau, J9A 1K7
Investigational Site Number 124009
Greenfield Park, J4V 4J2
Investigational Site Number 124014
Halifax, B3H 2E1
Investigational Site Number 124001
London, N6C 5J1
Investigational Site Number 124011
Montreal, H4H 1R3
Investigational Site Number 124008
Ottawa, K1G 4G3
Investigational Site Number 124013
Regina, S4T 1A5
Investigational Site Number 124003
Sherbrooke, J1H 4C4
Investigational Site Number 124006
St. John's, E2L 3L6
Investigational Site Number 124002
Toronto, M3B 2S7
Investigational Site Number 124004
Toronto, M4N 3M5
Australia9 sites
Investigational Site Number 036002
Adelaide, 5000
Investigational Site Number 036007
Chermside, 4032
Investigational Site Number 036008
Heidelberg West, 3081
Investigational Site Number 036006
Herston, 4029
Investigational Site Number 036001
Nedlands, 6009
Investigational Site Number 036004
Randwick, 2031
Investigational Site Number 036009
Toowoomba, 4350
Investigational Site Number 036005
Waratah, 2298
Investigational Site Number 036003
Woodville, 5011
France9 sites
Investigational Site Number 250004
Bordeaux, 33076
Investigational Site Number 250001
Lille, 59037
Investigational Site Number 250009
Limoges, 87042
Investigational Site Number 250007
Marseille, 13385
Investigational Site Number 250003
Nantes, 44035
Investigational Site Number 250005
Nice, 06000
Investigational Site Number 250006
Paris, 75013
Investigational Site Number 250008
Strasbourg, 67091
Investigational Site Number 250002
Toulouse, 31059
Germany6 sites
Investigational Site Number 276011
Berlin, 10629
Investigational Site Number 276012
Dresden, 01307
Investigational Site Number 276007
München, 80331
Investigational Site Number 276008
München, 80331
Investigational Site Number 276001
Schwerin, 19053
Investigational Site Number 276009
Würzburg, 97070
Italy6 sites
Investigational Site Number 380006
Ancona, 60020
Investigational Site Number 380004
Castellanza, 21053
Investigational Site Number 380005
Cefalù, 90015
Investigational Site Number 380002
Milan, 20122
Investigational Site Number 380001
Milan, 20132
Investigational Site Number 380003
Milan, 20162
Poland6 sites
Investigational Site Number 616004
Bydgoszcz, 85-796
Investigational Site Number 616003
Gdansk, 80-266
Investigational Site Number 616001
Gdynia, 81-361
Investigational Site Number 616002
Poznan, 61-289
Investigational Site Number 616006
Szczecin, 70-215
Investigational Site Number 616005
Warsaw, 02-507
Spain5 sites
Investigational Site Number 724002
Algorta, 48993
Investigational Site Number 724001
Barcelona, 08907
Investigational Site Number 724008
Madrid, 28029
Investigational Site Number 724007
Seville, 41007
Investigational Site Number 724003
Terrassa, 08221
Portugal2 sites
Investigational Site Number 620002
Amadora, 2720-276
Investigational Site Number 620001
Lisbon, 1649-035
About this study
Official title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy
Primary Objective:
- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy
Secondary Objectives:
- To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
- To assess the safety/tolerability of SAR110894;
- To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
- To explore caregiver time consumption and distress changes.
Read the detailed description
The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:
- Screening period: up to 4 weeks,
- Treatment period: 24 weeks,
- Follow-up period: 10 weeks.
- Conditions
- Dementia Alzheimer's Type
- Being tested
- SAR110894, placebo (for SAR110894), Donepezil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR110894Drug
Pharmaceutical form: Capsule
Route of administration: Oral
placebo (for SAR110894)Drug
Pharmaceutical form: Capsule
Route of administration: Oral
DonepezilDrug
5 mg or 10 mg once daily continued as taken before inclusion
| Study group | Role | What they receive |
|---|---|---|
| SAR110894 - 0.5 mg | Experimental | SAR110894, 0.5 mg once daily along with Donepezil. Receives: Drug: SAR110894; Drug: Donepezil |
| SAR110894 - 2 mg | Experimental | SAR110894, 2 mg once daily along with Donepezil. Receives: Drug: SAR110894; Drug: Donepezil |
| SAR110894 - 5 mg | Experimental | SAR110894, 5 mg once daily along with Donepezil. Receives: Drug: SAR110894; Drug: Donepezil |
| Placebo | Placebo comparator | Placebo (for SAR110894) once daily along with Donepezil. Receives: Drug: placebo (for SAR110894); Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
Measured: Week 4, 12, and 24
Secondary outcomes (4)
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Measured: Week 4, 12, and 24
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Measured: Week 4, 12, and 24
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Measured: Week 4, 12, and 24
Change from baseline in the Mini Mental State Examination (MMSE) total score
Measured: Week 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dementia Alzheimer's TypeStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266525
- Sponsor's protocol ID
- DRI10734
- Other IDs
- 2010-022596-64, U1111-1115-7535
- Status last verified
- Feb 2016
- First submitted
- 23 Dec 2010
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PubMed 33189083Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.
PubMed 27662321
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy
- ClinicalTrials.gov ID
- NCT01266525
- Acronym / sponsor ID
- DRI10734
- Conditions
- Dementia Alzheimer's Type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Dec 2010 (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.
Primary Objective:
- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy
Secondary Objectives:
- To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
- To assess the safety/tolerability of SAR110894;
- To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
- To explore caregiver time consumption and distress changes.
Detailed description
The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:
- Screening period: up to 4 weeks,
- Treatment period: 24 weeks,
- Follow-up period: 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAR110894 - 0.5 mg | Experimental | Drug: SAR110894, Drug: DonepezilSAR110894, 0.5 mg once daily along with Donepezil. |
| SAR110894 - 2 mg | Experimental | Drug: SAR110894, Drug: DonepezilSAR110894, 2 mg once daily along with Donepezil. |
| SAR110894 - 5 mg | Experimental | Drug: SAR110894, Drug: DonepezilSAR110894, 5 mg once daily along with Donepezil. |
| Placebo | Placebo comparator | Drug: placebo (for SAR110894), Drug: DonepezilPlacebo (for SAR110894) once daily along with Donepezil. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).
- Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit.
Key exclusion criteria (5 listed)
- Age <55 years old.
- Psychotic features, agitation, or behavioral problems within the last 3 months.
- Patients unable to comply with ophthalmologic monitoring.
- Lack of consistent and reliable caregiver.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| SAR110894Pharmaceutical form: Capsule Route of administration: Oral | Drug | SAR110894 - 0.5 mg, SAR110894 - 2 mg, SAR110894 - 5 mg |
| placebo (for SAR110894)Pharmaceutical form: Capsule Route of administration: Oral | Drug | Placebo |
| Donepezil5 mg or 10 mg once daily continued as taken before inclusion | Drug | Placebo, SAR110894 - 0.5 mg, SAR110894 - 2 mg, SAR110894 - 5 mg |
Primary outcome
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
Time frame: Week 4, 12, and 24
4 secondary outcomes
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Time frame: Week 4, 12, and 24
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Time frame: Week 4, 12, and 24
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Time frame: Week 4, 12, and 24
Change from baseline in the Mini Mental State Examination (MMSE) total score
Time frame: Week 4, 12, and 24
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 14 Mar 2016.
- Derived from this study: PubMed 33189083McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
- Derived from this study: PubMed 27662321Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.
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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 Sciences & Operations study director
Sanofi
82 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR110894 and Donepezil in people with Dementia Alzheimer's Type, run by Sanofi at 82 sites in 9 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 2 inclusion and 5 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Canada, Australia, France, Germany and 4 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 to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). (time frame: Week 4, 12, and 24). 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 NCT01266525, which also lists 2 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 14 Mar 2016.