Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01009476 |
|
Recruitment Status :
Completed
First Posted : November 6, 2009
Last Update Posted : June 18, 2014
|
Sponsor:
Janssen-Cilag G.m.b.H
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The main objective of this non-interventional study was to document the long-term application of galantamine and nootropics (memory enhancing drugs) over a period of 1 year under conditions of daily routine. There were no predefined specifications of diagnostic and therapeutic measures. The decision for treatment with either galantamine or a nootropic had to be made by the treating physician prior to the start of documentation. The following measures were to be documented: safety, tolerability, dementia-associated symptoms (unstable walking, vertigo, awakening at night, shouting/screaming at night, perambulating at night, aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, behavior that poses a risk to self or others, and daytime tiredness), frequency of admissions to nursing homes or nursing services, global functional level, caregiver's burden, and time spent on caregiving. Furthermore, this study aimed to gather knowledge on the differentiated use of the two treatment strategies considering the specific diagnosis of dementia (e.g. Alzheimer's disease only or mixed dementia, i.e. Alzheimer's disease and cerebrovascular disease) and risk profiles.
| Condition or disease | Intervention/treatment |
|---|---|
| Dementia Alzheimer Disease Dementia, Vascular | Drug: Galantamine Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others) |
The aim of this observational, non-interventional study was to observe and document for a 1-year period, the long-term use of galantamine and nootropics (memory enhancing drugs) over a 1 year period under conditions of daily routine in a typical patient population of patients with mild or moderate Alzheimer's dementia or with mixed dementia, i.e. Alzheimer's and cerebrovascular disease. The design of this prospective study was non-interventional and thus, there were no predefined specifications of diagnostic and therapeutic measures. The decision for treatment with either galantamine or a nootropic agent had to be made by the treating physician prior to the start of documentation. Patients were observed over a period of 12 months or until end of documentation (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). The following measures were to be documented: safety by documenting adverse and serious adverse events together with severity, outcome and causality to the treatment; tolerability; vital functions; Global Deterioration Scale (GDS) staging system assessing global functioning; Mini-Mental State Examination assessing cognitive functions; dementia-associated behavioural symptoms (unstable walking, vertigo, awakening at night, shouting/screaming at night, perambulating at night, aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, behavior that poses a risk to self or others, and daytime tiredness); frequency of admissions to nursing homes or nursing services; caregiver's burden and time spent on caregiving (based on daily and weekly caregiving tasks); final evaluation of the therapy with galantamine or nootropics through the treating physician. Furthermore, this study aimed to gather knowledge on the differentiated use of the two treatment strategies considering the specific diagnosis of dementia (e.g. Alzheimer's disease only or mixed dementia, i.e. Alzheimer's disease and cerebrovascular disease) and risk profiles. Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. Therapy decisions were to be based on medical needs. The treatment regimen of galantamine (8 mg,16 mg, 24 mg retard capsule) or nootropic agents (e.g. ginkgo biloba, dihydroergotoxine, nicergoline, piracetam, or others) was to be in accordance with the recommendations given in the summary of product characteristics (SmPC).
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
| 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. |
Primary Outcome Measures :
- 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) ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
Study Population
Patients with mild or moderate Alzheimer dementia with or without cerebrovascular disease
Criteria
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
Information from the National Library of Medicine
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
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
| 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 |
Keywords provided by Janssen-Cilag G.m.b.H:
|
Dementia Galantamine Cholinesterase inhibitors Nootropic agents Alzheimer |
Vascular dementia Cognitive symptoms Behavioural symptoms Care giving times |
Additional relevant MeSH terms:
|
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 |