Alzheimer's DiseasePhase 1NCT01485302
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
A Phase 1 study testing SAR228810 in people with Alzheimer's Disease, run by Sanofi at 8 sites in 5 countries.
Trial summary
Primary Objective: To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD) Secondary Objective: To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SAR228810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jan 2012to Feb 2015
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive
- Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association
- Mini-mental state examination (MMSE)
- In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment
- Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease
- Rosen Modified Hachinski Ischemic score
- If on symptomatic treatment for Alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening
Who cannot join
- Clinically significant neurological disease other than Alzheimer's disease
- Had a major psychiatric disorder
- Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)
- History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.
- History or presence of clinically relevant cardiac disease.
- Currently taking anticonvulsants, anti-Parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. Concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (ASA) at a dose ≤ 160 mg/day;
- 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
8 sites in 5 countries.
8 sites in 5 countries
Sweden3 sites
Investigational Site Number 752003
Malmö, 21224
Investigational Site Number 752002
Mölndal, 43141
Investigational Site Number 752001
Stockholm, 14186
France2 sites
Investigational Site Number 250001
Pierre-Bénite, 69310
Investigational Site Number 250002
Toulouse, 31059
About this study
Official title: A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.
Primary Objective:
- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)
Secondary Objective:
- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients
Read the detailed description
14.5 to 22 months
- Conditions
- Alzheimer's Disease
- Being tested
- SAR228810
- Keywords
- mild to moderate 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.
SAR228810Drug
Pharmaceutical form:solution
Route of administration: intravenous
SAR228810Drug
Pharmaceutical form:solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 IV infusion Receives: Drug: SAR228810 |
| Cohort 2 | Experimental | Dose 2 IV infusion Receives: Drug: SAR228810 |
| Cohort 3 | Experimental | Dose 3 IV infusion Receives: Drug: SAR228810 |
| Cohort 4 | Experimental | Dose 4 IV infusion Receives: Drug: SAR228810 |
| Cohort 5 | Experimental | Dose 1 SC injection Receives: Drug: SAR228810 |
| Cohort 6 | Experimental | Dose 2 SC injection Receives: Drug: SAR228810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse events
Measured: 10 months
Secondary outcomes (6)
AUC
Measured: 1 to 112 days after dosing
Cmax
Measured: 1 to 112 days after dosing
t1/2z
Measured: 1 to 112 days after dosing
brain magnetic resonance imaging
Measured: 10 months
hematology, biochemistry, coagulation
Measured: 10 months
vital signs, ECG
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT01485302
- Sponsor's protocol ID
- TDR12399
- Other IDs
- 2011-002910-35, U1111-1120-0550
- Status last verified
- Mar 2015
- First submitted
- 16 Nov 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT01485302
- Acronym / sponsor ID
- TDR12399
- Conditions
- Alzheimer's Disease
- Keywords
- mild to moderate Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Dec 2011 (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 assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)
Secondary Objective:
- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients
Detailed description
14.5 to 22 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SAR228810Dose 1 IV infusion |
| Cohort 2 | Experimental | Drug: SAR228810Dose 2 IV infusion |
| Cohort 3 | Experimental | Drug: SAR228810Dose 3 IV infusion |
| Cohort 4 | Experimental | Drug: SAR228810Dose 4 IV infusion |
| Cohort 5 | Experimental | Drug: SAR228810Dose 1 SC injection |
| Cohort 6 | Experimental | Drug: SAR228810Dose 2 SC injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive
- Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association
- Mini-mental state examination (MMSE)
- In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment
- Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease
Key exclusion criteria (7 listed)
- Clinically significant neurological disease other than Alzheimer's disease
- Had a major psychiatric disorder
- Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)
- History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.
- History or presence of clinically relevant cardiac disease.
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 |
|---|---|---|
| SAR228810Pharmaceutical form:solution Route of administration: intravenous | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| SAR228810Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Cohort 5, Cohort 6 |
Primary outcome
number of patients with adverse events
Time frame: 10 months
6 secondary outcomes
AUC
Time frame: 1 to 112 days after dosing
Cmax
Time frame: 1 to 112 days after dosing
t1/2z
Time frame: 1 to 112 days after dosing
brain magnetic resonance imaging
Time frame: 10 months
hematology, biochemistry, coagulation
Time frame: 10 months
vital signs, ECG
Time frame: 10 months
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 25 Mar 2015.
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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
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR228810 in people with Alzheimer's Disease, run by Sanofi at 8 sites in 5 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 7 inclusion and 7 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, France, Bulgaria, Netherlands, South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
number of patients with adverse events (time frame: 10 months). 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 25 Mar 2015.