Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT01009476
First received: November 5, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Dementia
Alzheimer Disease
Dementia, Vascular
Drug: Galantamine
Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-interventional Study on Long-term Application of Galantamine and Nootropics in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag G.m.b.H:

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) ] [ Designated as safety issue: No ]

Enrollment: 1134
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT01009476     History of Changes
Other Study ID Numbers: CR011689
Study First Received: November 5, 2009
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Dementia
Dementia, Vascular
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Vascular Diseases
Galantamine
Nootropic Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014