Skip to main content
OpenTrials
Completed

NCT Number: NCT00276510

A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints

The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Memory Disorders, Age-Related Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retention Disorders, Cognitive Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1 rue de l'Orient, Agde, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneously reporting a memory complaint
  • Short anxiety battery test < 6, (only if patient screened at GP site)
  • Geriatric depression scale < 15
  • Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale)

Exclusion criteria

  • Objective memory impairment
  • Clinician rated dementia staging system > 0.5
  • Mini-mental state < 25
  • Dementia, past history of seizures, Parkinson disease

Treatment and study plan

EGb 761® (Tanakan®)

Drug

120 mg, 1 tablet twice a day, oral route, during 5 years.

Placebo

Other

1 tablet twice a day, oral route, during 5 years.

Primary outcomes

  1. EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis

    Time frame: Baseline, month 12, 24, 36, 48 and 60

Secondary outcomes

  1. Efficacy on rate of cognitive abilities decline

    Time frame: Baseline, month 12, 24, 36, 48 and 60

  2. Effect on concomitant diseases

    Time frame: Baseline, month 12, 24, 36, 48 and 60

  3. Concomitant treatments' reports

    Time frame: Baseline, month 12, 24, 36, 48 and 60

  4. Global evaluation of memory complaint by the patient

    Time frame: Baseline, month 12, 24, 36, 48 and 60

  5. Clinical safety

    Time frame: Baseline, month 12, 24, 36, 48 and 60

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2006
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.