Alzheimer's DiseasePhase 1NCT03307993
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
A Phase 1 study testing Idalopirdine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Idalopirdine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 19 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD.
- The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient.
- The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2.
Who cannot join
- The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)
- Conditions
- Alzheimer's Disease
- Being tested
- Idalopirdine
- Keywords
- Lu AE58054
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdalopirdineDrug
Also called Lu AE58054
Idalopirdine 60-120 mg daily dose
| Study group | Role | What they receive |
|---|---|---|
| Idalopirdine | Experimental | Idalopirdine 60 mg once daily for 10 day (up to 14 days possible), adjunct to donezepil (patients individualized maintenance dose)
If high receptor occupancy cannot be verified, the receptor occupancy following a higher dose (up to 60 mg twice daily for 10-14 days) will be assessed in Cohort 2. Receives: Drug: Idalopirdine |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-HT6 Receptor Occupancy (RO)
RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential
Measured: Treatment day 10 (24 hours post dose)
Idalopirdine plasma concentration (CPET)
CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements).
Measured: Prior to and after PET scan on treatment day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start22 Sep 2017
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Why it stopped: The study was terminated for strategic reasons.
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 H. Lundbeck A/SThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307993
- Sponsor's protocol ID
- 17475A
- Status last verified
- Apr 2018
- First submitted
- 26 Sep 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03307993
- Acronym / sponsor ID
- 17475A
- Conditions
- Alzheimer's Disease
- Keywords
- Lu AE58054
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for strategic reasons.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- 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 investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idalopirdine | Experimental | Drug: IdalopirdineIdalopirdine 60 mg once daily for 10 day (up to 14 days possible), adjunct to donezepil (patients individualized maintenance dose) If high receptor occupancy cannot be verified, the receptor occupancy following a higher dose (up to 60 mg twice daily for 10-14 days) will be assessed in Cohort 2. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD.
- The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient.
- The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2.
Key exclusion criteria (2 listed)
- The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
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 |
|---|---|---|
| IdalopirdineAlso: Lu AE58054Idalopirdine 60-120 mg daily dose | Drug | Idalopirdine |
Primary outcome
5-HT6 Receptor Occupancy (RO)
Time frame: Treatment day 10 (24 hours post dose)
RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential
Idalopirdine plasma concentration (CPET)
Time frame: Prior to and after PET scan on treatment day 10
CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements).
Results and safety
The study was stopped early (reason given: The study was terminated for strategic reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
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 Idalopirdine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 4 Apr 2018. 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 States. 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 was stopped early (reason given: The study was terminated for strategic reasons.). Results are not available in the source record.
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?
5-HT6 Receptor Occupancy (RO) (time frame: Treatment day 10 (24 hours post dose)). 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 4 Apr 2018.