Alzheimer's DiseasePhase 2NCT01421056
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
A Phase 2 study testing CHF 5074 1x, CHF 5074 2x and CHF 5074 3x in people with Alzheimer's Disease, run by Chiesi Farmaceutici S.p.A. at 6 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CHF 5074 1x, CHF 5074 2x and CHF 5074 3x
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2011to Nov 2012
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
- MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
Who cannot join
- Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
- Any medical condition that could explain the patients cognitive deficits.
- CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
- MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
- Geriatric Depression Scale (30-point scale) score > 9 at screening.
- History of stroke.
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- Modified Hachinski ischemic scale score > 4 at screening.
- Women of childbearing potential.
- Vitamin B12 or folate deficiency.
- Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
- Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
- Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
- Concomitant use of memantine at dose > 20 mg/day.
- Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Memory Center of New Jersey, Inc.
Monroe Twp, New Jersey, 08831
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, 08755
Italy2 sites
Clinica Santa Maria, Div Neurologia
Castellanza
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milan
About this study
Official title: A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment
The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
- Conditions
- Alzheimer's Disease
- Being tested
- CHF 5074 1x, CHF 5074 2x, CHF 5074 3x
- 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 in the morning for 24 weeks
CHF 5074 2xDrug
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks
CHF 5074 3xDrug
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks
| 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 |
| CHF 5074 3x | Experimental | oral tablet, multidose Receives: Drug: CHF 5074 3x |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
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 Chiesi Farmaceutici S.p.A.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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel S. Ross, MD, Principal investigator, Memory Enhancement Center of America, Inc.Gabriella Bottini, Prof., Principal investigator, Osp. Niguarda Ca Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421056
- Sponsor's protocol ID
- CCD-1014-PR-0053 OLEP
- Other IDs
- 2010-024270-19
- Status last verified
- Jan 2014
- First submitted
- 5 Aug 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01421056
- Acronym / sponsor ID
- CCD-1014-PR-0053 OLEP
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Aug 2011 (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 and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 |
| CHF 5074 3x | Experimental | Drug: CHF 5074 3xoral tablet, multidose |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
- MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
Key exclusion criteria (14 listed)
- Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
- Any medical condition that could explain the patients cognitive deficits.
- CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
- MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
- Geriatric Depression Scale (30-point scale) score > 9 at screening.
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 in the morning for 24 weeks | Drug | CHF 5074 1x |
| CHF 5074 2xoral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks | Drug | CHF 5074 2x |
| CHF 5074 3xoral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks | Drug | CHF 5074 3x |
Primary outcome
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Time frame: 24 weeks
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 6 Feb 2014.
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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, Inc.
Gabriella Bottini, Prof. principal investigator
Osp. Niguarda Ca Granda
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 5074 1x, CHF 5074 2x and CHF 5074 3x in people with Alzheimer's Disease, run by Chiesi Farmaceutici S.p.A. at 6 sites in 2 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 14 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy. 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 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 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?
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment (time frame: 24 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 6 Feb 2014.