Alzheimer's DiseasePhase 1NCT01656525
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
A Phase 1 study testing Gantenerumab in people with Alzheimer's Disease, run by Chugai Pharmaceutical at 5 sites in Japan.
Trial summary
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Gantenerumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 5 sitesJapan
- Study dates
- Jun 2012to Jun 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
- Meet DSM-IV criteria for Dementia of the Alzheimer type
- MMSE score : 16 to 26 etc.
Who cannot join
- Meet the exclusion criteria of MRI at screening.
- A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.
- etc.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kansai region
Kansai
Kanto region,
Kanto
Kyushu region
Kyushu
Tokai region
Toakai
Tohoku region
Tōhoku
About this study
Official title: A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.
- Conditions
- Alzheimer's Disease
- Being tested
- Gantenerumab, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GantenerumabDrug
75 mg subcutaneous doses every 4 weeks for 24 weeks
GantenerumabDrug
105 mg subcutaneous doses every 4 weeks for 24 weeks
GantenerumabDrug
225 mg subcutaneous doses every 4 weeks for 24 weeks
PlaceboDrug
subcutaneous doses every 4 weeks for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Gantenerumab |
| 2 | Experimental | Not described Receives: Drug: Gantenerumab |
| 3 | Experimental | Not described Receives: Drug: Gantenerumab |
| 4 | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Measured: 36 weeks
Pharmacokinetic parameters of Gantenerumab in plasma
Measured: 36 weeks
CSF/plasma ratios of Gantenerumab.
Measured: Baseline, Day183
Secondary outcomes (3)
Change from baseline in plasma Abeta
Measured: Baseline,Day183
Change from baseline in plasma and CSF tau
Measured: Baseline,Day183
Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).
Measured: Baseline,Day85, 197, 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionJun 2014
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.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656525
- Sponsor's protocol ID
- JP22431
- Other IDs
- JapicCTI-121849
- Status last verified
- Sep 2014
- First submitted
- 5 Jun 2012
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients
- ClinicalTrials.gov ID
- NCT01656525
- Acronym / sponsor ID
- JP22431
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Aug 2012 (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.
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gantenerumab |
| 2 | Experimental | Drug: Gantenerumab |
| 3 | Experimental | Drug: Gantenerumab |
| 4 | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
- Meet DSM-IV criteria for Dementia of the Alzheimer type
- MMSE score : 16 to 26 etc.
Key exclusion criteria (3 listed)
- Meet the exclusion criteria of MRI at screening.
- A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.
- etc.
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 |
|---|---|---|
| Gantenerumab75 mg subcutaneous doses every 4 weeks for 24 weeks | Drug | 1 |
| Gantenerumab105 mg subcutaneous doses every 4 weeks for 24 weeks | Drug | 2 |
| Gantenerumab225 mg subcutaneous doses every 4 weeks for 24 weeks | Drug | 3 |
| Placebosubcutaneous doses every 4 weeks for 24 weeks | Drug | 4 |
Primary outcome
Number of participants with Adverse Events
Time frame: 36 weeks
Pharmacokinetic parameters of Gantenerumab in plasma
Time frame: 36 weeks
CSF/plasma ratios of Gantenerumab.
Time frame: Baseline, Day183
3 secondary outcomes
Change from baseline in plasma Abeta
Time frame: Baseline,Day183
Change from baseline in plasma and CSF tau
Time frame: Baseline,Day183
Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).
Time frame: Baseline,Day85, 197, 253
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 19 Sep 2014.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gantenerumab in people with Alzheimer's Disease, run by Chugai Pharmaceutical at 5 sites in Japan.
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 3 inclusion and 3 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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 participants with Adverse Events (time frame: 36 weeks). The study lists 3 primary outcomes in all. 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 19 Sep 2014.