Healthy Volunteer, Alzheimer's DiseasePhase 1NCT01701089
A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers
A Phase 1 study testing 11C-L-deprenyl-D2 and RO4602522 in people with Healthy Volunteer, Alzheimer's Disease, run by Hoffmann-La Roche at 1 site in Sweden.
Trial summary
This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with Alzheimer disease and in healthy volunteers. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Alzheimer's Disease
- What is being tested?
- 11C-L-deprenyl-D2 and RO4602522
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to May 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General:
- Adults between 50-80 years of age. Females must be of non-child-bearing potential or if of child-bearing potential must use an acceptable form of contraception
- Body mass index (BMI) 18.0-32.0 kg/m2 inclusive
- Healthy volunteers:
- Healthy, with no clinically relevant finding on physical examination at screening and Day -1
- No suspicion of cognitive impairment/early dementia from neuropsychological battery as judged by the investigator
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- Able to participate and willing to give informed consent, and comply with the study restrictions.
- Alzheimer Disease (AD) patients:
- Probable Alzheimer's disease, based on the National Institute of Neurological and Communicative
- Disorders and Stroke (NINCDS/ADRDA) and DSM-IV criteria
- Have a MMSE score at screening between 17 and 26 inclusive
- Modified Hachinski Ischemia Scale score of </=4
- A neuroimaging evaluation of the brain by MRI which supports a diagnosis of AD, with no evidence of focal disease to account for dementia or MRI exclusion criteria
- Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 1 month before Day 1.
- Able to participate in all scheduled evaluations
- The patient has an appropriate caregiver or community dwelling with caregiver capable of accompanying subject on all visits to the center as judged by the investigator.
- In the opinion of the investigator the patient and caregiver will be compliant and have a high probability of completing the study.
- Signed and dated written informed consent obtained from the patient, co-signed by the patient's closest relatives and legally authorized representative, as required by national law for patients that are incapable of giving informed consent.
Who cannot join
- General:
- Any active disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of drugs, including a history of major upper or middle GI tract surgery or current significant chronic disease of the GI tract
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening assessment
- History of cancer in the past five years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix
- Any major illness occurring within 1 month prior to the screening examination or febrile illness within 5 days prior to first dose
- History of psychotropic medicine abuse
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- At risk of suicide in the opinion of the investigator or having a Yes to question number 4 or 5 of the Suicidal Ideation section of the C-SSRS
- Administration of ionizing radiation or radioisotope for research, diagnostics test or therapy within 12 months prior to the present study which would exceed the local yearly radiation dose exposures for participation in research studies (except for dental x-rays, minimal plain films such as chest and ankle X-rays) or subjects who regularly work with ionizing radiation or radioactive material.
- Participation in a clinical study with an investigational drug within 3 months before screening
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14 days of screening.
- History of drug abuse or evidence of drug abuse in urine test performed at screening
- Current alcohol abuse, or regular intake of more than 2 units of alcohol daily
- Coffee (or tea) consumption > 5 cups per day or xanthine containing drinks >/1.5 liter/day
- Healthy volunteers:
- Family history of Alzheimer's disease in 1st and 2nd degree relative under 75 years.
- Evidence or history of clinically significant neurological or psychiatric disorders.
- AD Patients:
- Any neurological or psychiatric condition not specified in exceptions
- Previous immunization therapy for AD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Parallel Group Study to Assess the Inhibition of Brain MAO-B by RO4602522 After Repeated Dosing in Patients With Alzheimer's Disease and in Healthy Control Subjects
This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.
- Conditions
- Healthy Volunteer, Alzheimer's Disease
- Being tested
- 11C-L-deprenyl-D2, RO4602522
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-L-deprenyl-D2Drug
Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total
RO4602522Drug
Multiple doses of RO4602522 for 14 days
RO4602522Drug
Multiple doses of RO4602522 for up to 17 days
| Study group | Role | What they receive |
|---|---|---|
| RO4602522 Group 1 | Experimental | Not described Receives: Drug: 11C-L-deprenyl-D2; Drug: RO4602522 |
| RO4602522 Group 2 | Experimental | Not described Receives: Drug: 11C-L-deprenyl-D2; Drug: RO4602522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monoamine oxidase (MAO-B) enzyme activity as measured by in vivo positron emission tomography (PET)
Measured: Days 1, 14, and between days 15 and 34
Pharmacokinetics: Plasma concentration of RO4602522
Measured: Days 1, 8, 14, and between Days 15 and 34
Secondary outcomes (2)
Reduction of 11C-L-deprenyl-D2 tracer uptake by in vivo positron emission tomography (PET)
Measured: Days 1, 14, and between days 15 and 34
Safety: incidence of adverse events
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer, 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01701089
- Sponsor's protocol ID
- BP28253
- Status last verified
- Nov 2016
- First submitted
- 27 Sep 2012
- 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
- An Open-Label, Parallel Group Study to Assess the Inhibition of Brain MAO-B by RO4602522 After Repeated Dosing in Patients With Alzheimer's Disease and in Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01701089
- Acronym / sponsor ID
- BP28253
- Conditions
- Healthy Volunteer, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Oct 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.
This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO4602522 Group 1 | Experimental | Drug: 11C-L-deprenyl-D2, Drug: RO4602522 |
| RO4602522 Group 2 | Experimental | Drug: 11C-L-deprenyl-D2, Drug: RO4602522 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults between 50-80 years of age. Females must be of non-child-bearing potential or if of child-bearing potential must use an acceptable form of contraception
- Body mass index (BMI) 18.0-32.0 kg/m2 inclusive
- Healthy, with no clinically relevant finding on physical examination at screening and Day -1
- No suspicion of cognitive impairment/early dementia from neuropsychological battery as judged by the investigator
- Able to participate and willing to give informed consent, and comply with the study restrictions.
Key exclusion criteria (20 listed)
- Any active disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of drugs, including a history of major upper or middle GI tract surgery or current significant chronic disease of the GI tract
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening assessment
- History of cancer in the past five years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix
- Any major illness occurring within 1 month prior to the screening examination or febrile illness within 5 days prior to first dose
- History of psychotropic medicine abuse
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 |
|---|---|---|
| 11C-L-deprenyl-D2Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total | Drug | RO4602522 Group 1, RO4602522 Group 2 |
| RO4602522Multiple doses of RO4602522 for 14 days | Drug | RO4602522 Group 1 |
| RO4602522Multiple doses of RO4602522 for up to 17 days | Drug | RO4602522 Group 2 |
Primary outcome
Change in monoamine oxidase (MAO-B) enzyme activity as measured by in vivo positron emission tomography (PET)
Time frame: Days 1, 14, and between days 15 and 34
Pharmacokinetics: Plasma concentration of RO4602522
Time frame: Days 1, 8, 14, and between Days 15 and 34
2 secondary outcomes
Reduction of 11C-L-deprenyl-D2 tracer uptake by in vivo positron emission tomography (PET)
Time frame: Days 1, 14, and between days 15 and 34
Safety: incidence of adverse events
Time frame: 35 days
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11C-L-deprenyl-D2 and RO4602522 in people with Healthy Volunteer, Alzheimer's Disease, run by Hoffmann-La Roche at 1 site in Sweden.
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 18 inclusion and 20 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 1 site in Sweden. 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?
Change in monoamine oxidase (MAO-B) enzyme activity as measured by in vivo positron emission tomography (PET) (time frame: Days 1, 14, and between days 15 and 34). 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?
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.