Alzheimer's DiseasePhase 2CT05NCT01723670
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
A Phase 2 study testing CHF 5074 1x and CHF 5074 2x in people with Alzheimer's Disease, run by CERESPIR.
Trial summary
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CHF 5074 1x and CHF 5074 2x
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Mar 2016
- Phase
- Phase 2
- 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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
- Diagnosis of amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
Who cannot join
- Diagnosis of Alzheimer's disease.
- Any medical condition that could explain the subject's cognitive deficits.
- MRI scans having evidence of pre-specified brain abnormalities.
- History of stroke.
- Vitamin B12 or folate deficiency.
- Skin cancers and any cancer that is being actively treated.
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- Diagnosis of schizophrenia or recurrent mood disorder.
- Abnormal kidney function.
- Concomitant use of any study prohibitive medication.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.
- Conditions
- Alzheimer's Disease
- Being tested
- CHF 5074 1x, CHF 5074 2x, 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.
CHF 5074 1xDrug
oral tablet, 1x, once a day for 24 months
CHF 5074 2xDrug
oral tablet, 2x, once a day for 24 months
PlaceboDrug
oral tablet,once a day for 24 months
| Study group | Role | What they receive |
|---|---|---|
| CHF 5074 1x | Experimental | oral tablet, multidose Receives: Drug: CHF 5074 1x |
| CHF 5074 2x | Experimental | oral tablet, multidose Receives: Drug: CHF 5074 2x |
| Placebo | Placebo comparator | placebo, oral tablet, multidose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects on change from baseline on brain atrophy
Measured: pre-dose, Months 6, 12, 18, 24 and Washout
Secondary outcomes (2)
To determine the presence of other biomarkers of neuronal degeneration
Measured: Day 1
To determine the presence of other biomarkers of neuronal degeneration
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CERESPIR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel S Ross, MD, Principal investigator, Memory Enhancement Center of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723670
- Sponsor's protocol ID
- CCD-1109-PR-0072
- Acronym
- CT05
- Status last verified
- Feb 2015
- First submitted
- 31 Oct 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01723670
- Acronym / sponsor ID
- CT05 / CCD-1109-PR-0072
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CERESPIRIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Nov 2012 (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 evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF 5074 1x | Experimental | Drug: CHF 5074 1xoral tablet, multidose |
| CHF 5074 2x | Experimental | Drug: CHF 5074 2xoral tablet, multidose |
| Placebo | Placebo comparator | Drug: Placeboplacebo, oral tablet, multidose |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
- Diagnosis of amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
Key exclusion criteria (9 listed)
- Diagnosis of Alzheimer's disease.
- Any medical condition that could explain the subject's cognitive deficits.
- MRI scans having evidence of pre-specified brain abnormalities.
- History of stroke.
- Vitamin B12 or folate deficiency.
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 |
|---|---|---|
| CHF 5074 1xoral tablet, 1x, once a day for 24 months | Drug | CHF 5074 1x |
| CHF 5074 2xoral tablet, 2x, once a day for 24 months | Drug | CHF 5074 2x |
| Placebooral tablet,once a day for 24 months | Drug | Placebo |
Primary outcome
To determine the effects on change from baseline on brain atrophy
Time frame: pre-dose, Months 6, 12, 18, 24 and Washout
2 secondary outcomes
To determine the presence of other biomarkers of neuronal degeneration
Time frame: Day 1
To determine the presence of other biomarkers of neuronal degeneration
Time frame: Month 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Joel S Ross, MD principal investigator
Memory Enhancement Center of America
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 5074 1x and CHF 5074 2x in people with Alzheimer's Disease, run by CERESPIR.
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 9 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: withdrawn, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine the effects on change from baseline on brain atrophy (time frame: pre-dose, Months 6, 12, 18, 24 and Washout). 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 10 Feb 2015.