Alzheimer's DiseasePhase 1NCT02377713
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
A Phase 1 study testing KHK6640 in people with Alzheimer's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 55 to 84 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- KHK6640
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Sep 2016
- 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 55 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate Alzheimer's Disease
- Body weight ≥ 40 kg and < 100 kg
- Clinical Dementia Rating (CDR) score of 1 or 2
- Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26
Who cannot join
- Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
- Use of another investigational drug within 4 months prior to the enrollment
- Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
- Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- KHK6640, Placebo
- Keywords
- KHK6640, Phase 1, Japanese, single dose, 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.
KHK6640Drug
Single ascending dose administration
PlaceboDrug
Single ascending dose administration
| Study group | Role | What they receive |
|---|---|---|
| KHK6640 | Experimental | KHK6640 Receives: Drug: KHK6640 |
| Placebo | Placebo comparator | Placebo 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 as a Measure of Safety and Tolerability
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
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 Kyowa Kirin Co., Ltd.The 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377713
- Sponsor's protocol ID
- 6640-002
- Status last verified
- Dec 2016
- First submitted
- 25 Feb 2015
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT02377713
- Acronym / sponsor ID
- 6640-002
- Conditions
- Alzheimer's Disease
- Keywords
- KHK6640, Phase 1, Japanese, single dose, Alzheimer's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Mar 2015 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK6640 | Experimental | Drug: KHK6640KHK6640 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 55 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild to moderate Alzheimer's Disease
- Body weight ≥ 40 kg and < 100 kg
- Clinical Dementia Rating (CDR) score of 1 or 2
- Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26
Key exclusion criteria (6 listed)
- Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
- Use of another investigational drug within 4 months prior to the enrollment
- Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's 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 |
|---|---|---|
| KHK6640Single ascending dose administration | Drug | KHK6640 |
| PlaceboSingle ascending dose administration | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 90 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 7 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 KHK6640 in people with Alzheimer's Disease, run by Kyowa Kirin Co., Ltd. at 1 site 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 4 inclusion and 6 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 7 Dec 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 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. 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 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 as a Measure of Safety and Tolerability (time frame: Up to 90 days). 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 7 Dec 2016.