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

Phase 4

Completed

• Conditions: Memory Disorders, Age-Related; Retention Disorders, Cognitive
• Interventions: Drug: EGb 761® (Tanakan®); Other: Placebo

• Registration Number: NCT00276510
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2878

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	EGb 761® (Tanakan®)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis	Baseline, month 12, 24, 36, 48 and 60

Secondary Outcome Measures

Name	Time	Method
Clinical safety	Baseline, month 12, 24, 36, 48 and 60
Concomitant treatments' reports	Baseline, month 12, 24, 36, 48 and 60
Efficacy on rate of cognitive abilities decline	Baseline, month 12, 24, 36, 48 and 60
Effect on concomitant diseases	Baseline, month 12, 24, 36, 48 and 60
Global evaluation of memory complaint by the patient	Baseline, month 12, 24, 36, 48 and 60

Trial Locations

Locations (695)

1 rue de l'Orient; 🇫🇷 Agde, France

3 Avenue de Marlioz; 🇫🇷 Aix les Bains, France

3 rue Auguste Delaune; 🇫🇷 Ales, France

17 rue du Cardinal Georges d'Amboise; 🇫🇷 Amboise, France

17 rue Manuel; 🇫🇷 Amboise, France

83 rue Nicolas et Paul Paquet; 🇫🇷 Ancerville, France

10 bd De La Republique; 🇫🇷 Andernos Les Bains, France

107 bd De La Republique; 🇫🇷 Andernos Les Bains, France

19 rue Jean Saccheti; 🇫🇷 Andernos, France

128 Rue Bressigny; 🇫🇷 Angers, France

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