Alzheimer's DiseasePhase 2NCT02576639
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
A Phase 2 study testing CNP520 in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 11 sites in 5 countries.
Trial summary
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CNP520
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 10 Aug 2015to 11 Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy status
- Body weight: ≥45kg
- BMI: 18-34 kg/m2
Who cannot join
- History or presence of any clinically significant disease of any major system organ class.
- Heavy smoker status
- History /presence of clinically significant neurological or psychiatric disorders
- Any medical condition that might lead to or is associated with any cognitive deficit
- History or presence of severely impaired renal function
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States4 sites
Novartis Investigative Site
Glendale, California, 91206
Novartis Investigative Site
Lincoln, Nebraska, 68502
Novartis Investigative Site
Long Beach, California, 90806
Novartis Investigative Site
Miami, Florida, 33126
United Kingdom3 sites
Novartis Investigative Site
Belfast, Northern Ireland, BT9 6AD
Novartis Investigative Site
Harrow, HA1 3UJ
Novartis Investigative Site
Mid Glamorgan, CF484DR
Netherlands2 sites
Novartis Investigative Site
Groningen, GZ, 9713
Novartis Investigative Site
Leiden, 2333 CL
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
- Conditions
- Alzheimer's Disease
- Being tested
- CNP520, Placebo
- Keywords
- Alzheimer's Disease,, Amyloid Beta,, cerebrospinal fluid,, beta secretase
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNP520Drug
Also called CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.
PlaceboDrug
Matching placebo to CNP520 was supplied in capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. Receives: Drug: Placebo |
| CNP520 2 mg | Experimental | CNP520 2 mg was taken qd orally for 13 weeks. Receives: Drug: CNP520 |
| CNP520 10 mg | Experimental | CNP520 10 mg was taken qd orally for 13 weeks. Receives: Drug: CNP520 |
| CNP520 35 mg | Experimental | CNP520 35 mg was taken qd orally for 13 weeks. Receives: Drug: CNP520 |
| CNP520 85 mg | Experimental | CNP520 85 mg was taken qd orally for 13 weeks. Receives: Drug: CNP520 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Safety monitoring was conducted throughout the study.
Measured: 13 weeks
Secondary outcomes (11)
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
CSF samples were collected by lumbar puncture for assessment.
Measured: Day 92
Summary of Plasma PK Parameter: Cmax
Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.
Measured: Days 1, 91
Summary of Plasma PK Parameter: AUCtau
AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.
Measured: Days 1 and 91
Summary of Plasma PK Parameter: Tmax
Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
Measured: Days 1 and 91
Summary of Plasma PK Parameter: Tlag
Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.
Measured: Days 1 and 91
Summary of Plasma PK Parameter: T1/2
T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
Measured: Day 91
Summary of PK Parameter: CLss/F
CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.
Measured: Day 91
Summary of Plasma PK Parameter: Racc
Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Measured: Day 91
Summary of CSF PK Concentrations
CSF samples were collected by lumbar puncture for assessment.
Measured: Days 1, 14, 28, 42, 56, 70 and 91
Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
CNP520 concentrations in plasma
Measured: Day 91
Apparent Volume of Distribution (Vz/F)
Measured: Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start10 Aug 2015
- Primary completion11 Mar 2016
- Study completion11 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576639
- Sponsor's protocol ID
- CCNP520X2102
- Other IDs
- 2013-005576-18
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2015
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT02576639
- Acronym / sponsor ID
- CCNP520X2102
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease,, Amyloid Beta,, cerebrospinal fluid,, beta secretase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 11 Mar 2016 (actual)
- Study completion
- 11 Mar 2016 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. |
| CNP520 2 mg | Experimental | Drug: CNP520CNP520 2 mg was taken qd orally for 13 weeks. |
| CNP520 10 mg | Experimental | Drug: CNP520CNP520 10 mg was taken qd orally for 13 weeks. |
| CNP520 35 mg | Experimental | Drug: CNP520CNP520 35 mg was taken qd orally for 13 weeks. |
| CNP520 85 mg | Experimental | Drug: CNP520CNP520 85 mg was taken qd orally for 13 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy status
- Body weight: ≥45kg
- BMI: 18-34 kg/m2
Key exclusion criteria (5 listed)
- History or presence of any clinically significant disease of any major system organ class.
- Heavy smoker status
- History /presence of clinically significant neurological or psychiatric disorders
- Any medical condition that might lead to or is associated with any cognitive deficit
- History or presence of severely impaired renal function
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 |
|---|---|---|
| CNP520Also: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg. | Drug | CNP520 10 mg, CNP520 2 mg, CNP520 35 mg, CNP520 85 mg |
| PlaceboMatching placebo to CNP520 was supplied in capsules. | Drug | Placebo |
Primary outcome
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Time frame: 13 weeks
Safety monitoring was conducted throughout the study.
11 secondary outcomes
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Time frame: Day 92
Summary of Plasma PK Parameter: Cmax
Time frame: Days 1, 91
Summary of Plasma PK Parameter: AUCtau
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: Tmax
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: Tlag
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: T1/2
Time frame: Day 91
Summary of PK Parameter: CLss/F
Time frame: Day 91
Summary of Plasma PK Parameter: Racc
Time frame: Day 91
Summary of CSF PK Concentrations
Time frame: Days 1, 14, 28, 42, 56, 70 and 91
Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
Time frame: Day 91
Apparent Volume of Distribution (Vz/F)
Time frame: Day 91
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Study Director study director
Novartis Pharmaceuticals
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNP520 in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 11 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 3 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom, Netherlands, Belgium, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths (time frame: 13 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 11 Aug 2017.