Healthy VolunteerNCT01926873
A Screening Study To Assess The Cognition Status in Healthy Volunteers
An observational study of Healthy Volunteer, run by Hoffmann-La Roche at 12 sites in 3 countries.
Trial summary
This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 240 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Aug 2013to Jul 2014
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy volunteers, 18 to 65 years of age, inclusive
- Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
- A body mass index between 18 to 30 kg/m2 inclusive
- Able to participate and willing to give written informed consent and to comply with the study restrictions
- At least second generation resident in the country of origin
Who cannot join
- Current or past history of a psychiatric disorder
- Family history of psychiatric disorders
- Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
- Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
- Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
- Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
Show all 10Show fewer
- Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
- Resting Pulse Rate greater than 100 or less than 45 beats per minute
- Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
- Participation in an investigational drug study within 1 month prior to baseline
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States5 sites
Study site
Atlanta, Georgia, 30328
Study site
Cedarhurst, New York, 11516
Study site
Oak Brook, Illinois, 60523
Study site
Salt Lake City, Utah, 84106
Study site
San Diego, California, 92102
Germany4 sites
Study site
Freiburg im Breisgau, 79104
Study site
Mainz, 55131
Study site
Mannheim, 68159
Study site
Schwerin, Mecklenburg-Vorpommern, 19053
Poland3 sites
Study site
Bialystok, 15-464
Study site
Choroszcz, 16-070
Study site
Tuszyn, 95-080
About this study
Official title: MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION
This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.
- Conditions
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status of volunteers
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 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
- NCT01926873
- Sponsor's protocol ID
- BP28865
- Other IDs
- 2013-001261-16
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2013
- 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
- MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION
- ClinicalTrials.gov ID
- NCT01926873
- Acronym / sponsor ID
- BP28865
- Conditions
- Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Aug 2013 (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 multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- Healthy volunteers, 18 to 65 years of age, inclusive
- Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
- A body mass index between 18 to 30 kg/m2 inclusive
- Able to participate and willing to give written informed consent and to comply with the study restrictions
- At least second generation resident in the country of origin
Key exclusion criteria (10 listed)
- Current or past history of a psychiatric disorder
- Family history of psychiatric disorders
- Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
- Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
- Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive status of volunteers
Time frame: 6 weeks
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
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Hoffmann-La Roche at 12 sites in 3 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 10 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 12 sites in United States, Germany, Poland. 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.
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?
Cognitive status of volunteers (time frame: 6 weeks). 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.