Memory DisordersNCT00567060
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
A study testing Piracetam in people with Memory Disorders, run by UCB Pharma.
Trial summary
The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Memory Disorders
- What is being tested?
- Piracetam
- How many people
- 676 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jan 2004
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male/female between 50 and 89 years (inclusive)
- declining cognitive function of at least 3 months duration interfering with complex activities of daily living
- normal basic activities of daily independent living
- Clinical Dementia Rating scale score equal to 0.5
- score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit
Who cannot join
- general anesthetics within 3 months of selection visit
- history of severe allergic drug reaction(s)
- history of drug or alcohol dependence (DSM IV defined) within the last 12 months
- any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
- concomitant intake of anticoagulent medications
- concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system
Show all 12Show fewer
- history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke
- current depression
- impaired renal function, thyroid function or neurological degeneration
- any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug
- insulin-dependant diabetes mellitus
- bleeding disorders or disturbance in hemostatic function.
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)
The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.
- Conditions
- Memory Disorders
- Being tested
- Piracetam
- Keywords
- Piracetam, Nootropil
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiracetamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Battery Composite Score over a 52-week period
Secondary outcomes (1)
safety of piracetam for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startMay 2000
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567060
- Sponsor's protocol ID
- N01001
- Status last verified
- Sep 2009
- First submitted
- 30 Nov 2007
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jelic V, Kivipelto M, Winblad B. Clinical trials in mild cognitive impairment: lessons for the future. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):429-38. doi: 10.1136/jnnp.2005.072926. Epub 2005 Nov 23.
PubMed 16306154
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT00567060
- Acronym / sponsor ID
- N01001
- Conditions
- Memory Disorders
- Keywords
- Piracetam, Nootropil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 4 Dec 2007 (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 was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male/female between 50 and 89 years (inclusive)
- declining cognitive function of at least 3 months duration interfering with complex activities of daily living
- normal basic activities of daily independent living
- Clinical Dementia Rating scale score equal to 0.5
- score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit
Key exclusion criteria (12 listed)
- general anesthetics within 3 months of selection visit
- history of severe allergic drug reaction(s)
- history of drug or alcohol dependence (DSM IV defined) within the last 12 months
- any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
- concomitant intake of anticoagulent medications
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 |
|---|---|---|
| Piracetam | Drug | – |
Primary outcome
Cognitive Battery Composite Score over a 52-week period
1 secondary outcome
safety of piracetam for 12 months
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 16 Dec 2013.
- Results publication: PubMed 16306154Jelic V, Kivipelto M, Winblad B. Clinical trials in mild cognitive impairment: lessons for the future. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):429-38. doi: 10.1136/jnnp.2005.072926. Epub 2005 Nov 23.
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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.
UCB Clinical Trial Call Center study director
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A study testing Piracetam in people with Memory Disorders, run by UCB Pharma.
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 12 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 16 Dec 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cognitive Battery Composite Score over a 52-week period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00567060, which also lists 1 linked publication.
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 16 Dec 2013.