NCT00446485

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

March 12, 2007

Last Update Submit

September 24, 2015

Conditions

Mild Cognitive ImpairmentCerebrovascular Insufficiency

Keywords

ginkgo bilobacerebrovascular insufficiencymild cognitive impairmentconcentration impairment

Outcome Measures

Primary Outcomes (5)

  • Changes of MDRS

    6 months

  • Changes of VFT

    6 months

  • Changes of CGI

    6 months

  • Changes of SCAG

    6 months

  • Changes of MMSE

    6 months

Secondary Outcomes (4)

  • Changes of TCD, and color Doppler of carotid arteries

    6 months

  • Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time

    6 months

  • Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

    6 months

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

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Ginkgo Biloba standardized extract 24/6

Drug: Ginkgo biloba standardized extract 24/6

3

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Ginkgo Biloba standardized extract 24/6DRUG

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

1
placeboDRUG

placebo during 6 months

3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Cognitive DysfunctionCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Vida Demarin, MD PHD

    University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FAAN, FAHA, FESO Fellow of Croatian Academy of Sciences and Arts Professor of Neurology

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

CR(1)