Alzheimer's DiseasePhase 1NCT02127476
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease
A Phase 1 study testing KHK6640 in people with Alzheimer's Disease, run by Kyowa Kirin Co., Ltd. at 9 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD. Read more about this study
- Who is it for?
- Ages 55 years and older
- 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
- 57 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jul 2014to May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prodromal AD or mild to moderate AD
- Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
- Have a cognitive impairment
- Low Aβ and high Tau in Cerebrospinal fluid (CSF)
- Mini Mental State Examination (MMSE) score > 16 at Screening
Who cannot join
- Previous active treatment with an AD immunotherapy in an investigational study
- Use of another investigational drug within 30 days of screening
- History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
- Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Sweden3 sites
Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
Malmö, SE-205 02
Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
Mölndal, SE-43141
Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit
Stockholm, SE-141 86
Netherlands2 sites
Department of Neurology and Alzheimer Center, VU University Medical Center
Amsterdam, 1081 GM
University Medical Centre Groningen (UMCG), Alzheimer Research Centre
Groningen, 9700 RB
Serbia2 sites
Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
Belgrade, 11 000
Military Medical Academy, Crnotravska 17,
Belgrade, 11 000
Finland1 site
Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
Turku, FI-20520
About this study
Official title: A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.
- Conditions
- Alzheimer's Disease
- Being tested
- KHK6640, Matching 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.
KHK6640Drug
Single ascending dose and multiple ascending doses administration
Matching PlaceboDrug
Single ascending dose and multiple ascending doses administration
| Study group | Role | What they receive |
|---|---|---|
| KHK6640 | Experimental | KHK6640 Receives: Drug: KHK6640 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Matching 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
Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2017
- Study completionMay 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127476
- Sponsor's protocol ID
- 6640-001
- Other IDs
- 2013-002873-23
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2014
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02127476
- Acronym / sponsor ID
- 6640-001
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Jul 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Apr 2014 (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 and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK6640 | Experimental | Drug: KHK6640KHK6640 |
| Placebo | Placebo comparator | Drug: Matching PlaceboPlacebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with prodromal AD or mild to moderate AD
- Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
- Have a cognitive impairment
- Low Aβ and high Tau in Cerebrospinal fluid (CSF)
- Mini Mental State Examination (MMSE) score > 16 at Screening
Key exclusion criteria (5 listed)
- Previous active treatment with an AD immunotherapy in an investigational study
- Use of another investigational drug within 30 days of screening
- History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
- Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
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 and multiple ascending doses administration | Drug | KHK6640 |
| Matching PlaceboSingle ascending dose and multiple ascending doses administration | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 7 months
Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI
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 17 Jun 2024.
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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.
9 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 KHK6640 in people with Alzheimer's Disease, run by Kyowa Kirin Co., Ltd. at 9 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 5 inclusion and 5 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden, Netherlands, Serbia, Belgium, Finland. 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 7 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 17 Jun 2024.