Alzheimer DiseasePhase 2NCT00500500
Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing EGb 761® (Tanakan®) in people with Alzheimer Disease, run by Ipsen at 1 site in France.
Trial summary
The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- EGb 761® (Tanakan®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to Apr 2008
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female or male of 50 to 85 years old with a care giver
- Mini Mental Status (MMS) test between 16 to 26 inclusive
- Clinical Dementia Rating (CDR) test inferior or equal to 1
- National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia
Who cannot join
- patient already treated by medicines which could interfere with the study
- low level of vitamin B12 and folate which are considered as clinically relevant
- clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness….)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.
The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- EGb 761® (Tanakan®)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb 761® (Tanakan®)Drug
| Study group | Role | What they receive |
|---|---|---|
| EGb 761® (Tanakan®) | Experimental | EGb 761® (Tanakan®) Receives: Drug: EGb 761® (Tanakan®) |
| Placebo | Placebo comparator | Placebo Receives: Drug: EGb 761® (Tanakan®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
Measured: Every visit
Secondary outcomes (1)
Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day
Measured: Every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJul 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Inability to recruit sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500500
- Sponsor's protocol ID
- 2-29-00240-127
- Status last verified
- Oct 2013
- First submitted
- 11 Jul 2007
- Last updated
- 26 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.
- ClinicalTrials.gov ID
- NCT00500500
- Acronym / sponsor ID
- 2-29-00240-127
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit sufficient number of patients
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Jul 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 aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGb 761® (Tanakan®) | Experimental | Drug: EGb 761® (Tanakan®)EGb 761® (Tanakan®) |
| Placebo | Placebo comparator | Drug: EGb 761® (Tanakan®)Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female or male of 50 to 85 years old with a care giver
- Mini Mental Status (MMS) test between 16 to 26 inclusive
- Clinical Dementia Rating (CDR) test inferior or equal to 1
- National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia
Key exclusion criteria (3 listed)
- patient already treated by medicines which could interfere with the study
- low level of vitamin B12 and folate which are considered as clinically relevant
- clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness….)
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 |
|---|---|---|
| EGb 761® (Tanakan®) | Drug | EGb 761® (Tanakan®), Placebo |
Primary outcome
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
Time frame: Every visit
1 secondary outcome
Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day
Time frame: Every visit
Results and safety
The study was stopped early (reason given: Inability to recruit sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGb 761® (Tanakan®) in people with Alzheimer Disease, run by Ipsen at 1 site in France.
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 3 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 26 Jun 2023. 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 France. 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?
The study was stopped early (reason given: Inability to recruit sufficient number of patients). 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?
Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets. (time frame: Every visit). 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 26 Jun 2023.