Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine
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ClinicalTrials.gov Identifier: NCT01009476 |
Recruitment Status :
Completed
First Posted : November 6, 2009
Last Update Posted : June 18, 2014
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Condition or disease | Intervention/treatment |
---|---|
Dementia Alzheimer Disease Dementia, Vascular | Drug: Galantamine Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others) |
Study Type : | Observational |
Actual Enrollment : | 1134 participants |
Time Perspective: | Prospective |
Official Title: | Non-interventional Study on Long-term Application of Galantamine and Nootropics in Patients With Alzheimer's Disease |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Group/Cohort | Intervention/treatment |
---|---|
001 |
Drug: Galantamine
Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of galantamine (8 mg,16 mg, 24 mg retard capsule) was to be in accordance with the recommendations given in the summary of product characteristics. |
002 |
Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)
Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of nootropics was to be in accordance with the recommendations given in the relevant summary of product characteristics. |
- documentation of the long-term use of galantamine and nootropics over a 1 year period under conditions of daily routine in patients with Alzheimer's disease (with or without vascular pathology) [ Time Frame: approx. 12 months or until end of observation ( visit 1 = baseline; visit 2, 3 and 4 after approximately 2, 6 and 9 months, respectively; visit 5 after approximately 12 months or final visit at end of documentation) ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients were selected for documentation after the decision of treatment (galantamine or nootropic) had been made by the treating physician. Patients documented in this study were required to meet the following selection criteria: Diagnosis of probable mild or moderate dementia: Alzheimer type or mixed dementia (Alzheimer's and cerebrovascular disease)
- Mini-Mental-State Examination score = 24 at baseline (Visit 1), if possible
- Monotherapy with either galantamine or nootropic (the decision for treatment with either galantamine or a nootropic had to be made by the treating physician prior to the start of documentation)
- Patient had a caregiver to whom personal contact was possible at least 3 times per week
Exclusion Criteria:
- Patients were not eligible if they had received anti-dementive treatment with acetylcholinesterase inhibitors, memantine, or the same nootropic used during the observational period within the last 12 weeks prior to baseline

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009476
Study Director: | Janssen-Cilag G.m.b.H. Clinical Trial | Janssen-Cilag G.m.b.H |
Responsible Party: | Janssen-Cilag G.m.b.H |
ClinicalTrials.gov Identifier: | NCT01009476 |
Other Study ID Numbers: |
CR011689 |
First Posted: | November 6, 2009 Key Record Dates |
Last Update Posted: | June 18, 2014 |
Last Verified: | June 2014 |
Dementia Galantamine Cholinesterase inhibitors Nootropic agents Alzheimer |
Vascular dementia Cognitive symptoms Behavioural symptoms Care giving times |
Alzheimer Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arterial Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Dementia Dementia, Vascular Tauopathies |
Intracranial Arteriosclerosis Leukoencephalopathies Arteriosclerosis Nicergoline Piracetam Galantamine Nootropic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Parasympathomimetics Autonomic Agents |