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Mild Cognitive ImpairmentPhase 4NCT00446485

Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency

A Phase 4 study testing Ginkgo biloba standardized extract 24/6 in people with Mild Cognitive Impairment and Cerebrovascular Insufficiency, run by Milsing d.o.o. at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ginkgo biloba standardized extract 24/6
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteCroatia
Study dates
May 2007to Apr 2010
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)

Who cannot join

  • pregnancy
  • cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder
  • alcohol or drug abuse

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment

The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment

Read the detailed description

Inclusion criteria is cerebrovascular insufficiency MNSE>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.

Being tested
Ginkgo biloba standardized extract 24/6, placebo
Keywords
ginkgo biloba, cerebrovascular insufficiency, mild cognitive impairment, concentration impairment
Medical subject headings
Cognitive Dysfunction, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgo biloba standardized extract 24/6Drug

    tablets, 120 mg/day (60 mg two times daily) during 6 months

  • Ginkgo Biloba standardized extract 24/6Drug

    tablets, 60 mg/day during 6 months

  • placeboDrug

    placebo during 6 months

Study groups in NCT00446485
Study groupRoleWhat they receive
1Active comparatorGinkgo Biloba standardized extract 24/6
Receives: Drug: Ginkgo biloba standardized extract 24/6
3Placebo comparatorplacebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of MDRS

    Measured: 6 months

  2. Changes of VFT

    Measured: 6 months

  3. Changes of CGI

    Measured: 6 months

  4. Changes of SCAG

    Measured: 6 months

  5. Changes of MMSE

    Measured: 6 months

Secondary outcomes (4)

  1. Changes of TCD, and color Doppler of carotid arteries

    Measured: 6 months

  2. Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time

    Measured: 6 months

  3. Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

    Measured: 6 months

  4. Safety will be assessed according to occurrence of adverse events during the trial

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446485
Sponsor's protocol ID
MIL-001
Status last verified
Sep 2015
First submitted
12 Mar 2007
Last updated
28 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ginkgo biloba standardized extract 24/6 in people with Mild Cognitive Impairment and Cerebrovascular Insufficiency, run by Milsing d.o.o. at 1 site in Croatia.

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 1 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: finished, as of the sponsor's last update on 28 Sep 2015. 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 Croatia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Changes of MDRS (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT00446485.

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 28 Sep 2015.

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