Alzheimer's DiseasePhase 1NCT02546310
Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
A Phase 1 study testing HTL0009936 in people with Alzheimer's Disease, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- HTL0009936
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Feb 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy on the basis of medical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, urinalysis and a pre-study psychological assessment.
- Mini Mental State Examination (MMSE) Score of ≥24.
- Intermediate or extensive metaboliser as determined by CYP2D6 genotype.
- Fluent English speaker.
- Right-handed.
- Not a regular smoker
Who cannot join
- Recreational drug use within 3 months prior to Screening Visit.
- Positive alcohol breath test.
- Positive urine drug screen.
- Consumption of large amounts of caffeinated drinks.
- Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges.
- Ultra-rapid or poor metabolizer as determined by CYP2D6 genotype.
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- By self-report, taking two or more daytime naps per week which in the opinion of the investigator is likely to interfere with the ability of the subject to complete the study procedures.
- History of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions.
- Personal or family history of congenital long QT syndrome or sudden death.
- Concomitant use of drugs that are metabolised by and/or are inhibitors of CYP2D6.
- Concomitant use of drugs that are substrates for the organic cation transporter 2.
- History of significant claustrophobia.
- Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neuroscience and Psychiatry Unit
Manchester, M13 9PT
About this study
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Phase 1, Exploratory Study Investigating the Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning.
- Conditions
- Alzheimer's Disease
- Being tested
- HTL0009936, HTL0009936 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.
HTL0009936Drug
HTL0009936 matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| HTL0009936 high dose | Experimental | high dose infusion Receives: Drug: HTL0009936 |
| HTL0009936 low dose | Experimental | low dose infusion Receives: Drug: HTL0009936 |
| HTL0009936 matching placebo | Placebo comparator | matching infusion Receives: Drug: HTL0009936 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
Measured: Day 1
Secondary outcomes (5)
BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks
Measured: Day 1
cerebral blood flow, assessed using Arterial Spin Labelling (ASL)
Measured: Day 1
adverse events
Measured: Day 1
blood pressure
Measured: Day 1
12-lead electrocardiogram
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completionFeb 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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- P1vital Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546310
- Sponsor's protocol ID
- 9936-103
- Status last verified
- Feb 2017
- First submitted
- 1 Sep 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Phase 1, Exploratory Study Investigating the Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT02546310
- Acronym / sponsor ID
- 9936-103
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- P1vital Limited
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Sep 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.
To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HTL0009936 high dose | Experimental | Drug: HTL0009936high dose infusion |
| HTL0009936 low dose | Experimental | Drug: HTL0009936low dose infusion |
| HTL0009936 matching placebo | Placebo comparator | Drug: HTL0009936 matching placebomatching infusion |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Healthy on the basis of medical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, urinalysis and a pre-study psychological assessment.
- Mini Mental State Examination (MMSE) Score of ≥24.
- Intermediate or extensive metaboliser as determined by CYP2D6 genotype.
- Fluent English speaker.
- Right-handed.
Key exclusion criteria (13 listed)
- Recreational drug use within 3 months prior to Screening Visit.
- Positive alcohol breath test.
- Positive urine drug screen.
- Consumption of large amounts of caffeinated drinks.
- Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges.
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 |
|---|---|---|
| HTL0009936 | Drug | HTL0009936 high dose, HTL0009936 low dose |
| HTL0009936 matching placebo | Drug | HTL0009936 matching placebo |
Primary outcome
Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks
Time frame: Day 1
5 secondary outcomes
BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during cognitive tasks
Time frame: Day 1
cerebral blood flow, assessed using Arterial Spin Labelling (ASL)
Time frame: Day 1
adverse events
Time frame: Day 1
blood pressure
Time frame: Day 1
12-lead electrocardiogram
Time frame: Day 1
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 3 Feb 2017.
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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 HTL0009936 in people with Alzheimer's Disease, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
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 6 inclusion and 13 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 3 Feb 2017. 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 United Kingdom. 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?
Blood oxygen level dependent (BOLD) signal in functional Magnetic Resonance Imaging (fMRI) of the brain areas associated with cognitive tasks (time frame: Day 1). 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 3 Feb 2017.