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

Ipsen

Status and phase: Completed; Phase 4

Conditions: Retention Disorders, Cognitive; Memory Disorders, Age-Related

Treatments: Other: Placebo; Drug: EGb 761® (Tanakan®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276510

2-31-00240-011

Details and patient eligibility

About

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.

Enrollment: 2,878 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,878 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: EGb 761® (Tanakan®)

2

Placebo Comparator group

Treatment:

Other: Placebo