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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
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H

Tracking Information
First Submitted Date November 5, 2009
First Posted Date November 6, 2009
Last Update Posted Date June 18, 2014
Study Start Date March 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2009)
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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: November 5, 2009)
No Secondary Outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine
Official Title Non-interventional Study on Long-term Application of Galantamine and Nootropics in Patients With Alzheimer's Disease
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.
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).
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with mild or moderate Alzheimer dementia with or without cerebrovascular disease
Condition
  • Dementia
  • Alzheimer Disease
  • Dementia, Vascular
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • 001
    Intervention: Drug: Galantamine
  • 002
    Intervention: Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 5, 2009)
1134
Original Actual Enrollment Same as current
Actual Study Completion Date August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01009476
Other Study ID Numbers CR011689
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen-Cilag G.m.b.H
Study Sponsor Janssen-Cilag G.m.b.H
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag G.m.b.H. Clinical Trial Janssen-Cilag G.m.b.H
PRS Account Janssen-Cilag G.m.b.H
Verification Date June 2014