Back to resultsSafety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
PYM50028
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring dementia, memory, Hopkins verbal learning test, paired associated learning
Eligibility Criteria
Inclusion Criteria: At least 50 years of age Diagnosis of possible or probable Alzheimer's disease Mini mental state examination score at least 16 Good understanding of both written and verbal English A recent head scan that is consistent with the diagnosis of Alzheimer's disease Exclusion Criteria: Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease Known to have another condition that is associated with dementia Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine) Hormone replacement therapy started or changed within the previous 6 months Received any investigational drugs within the previous 12 weeks
Sites / Locations
- Oxford Project to Investigate Memory and Ageing
Outcomes
Primary Outcome Measures
Hopkins verbal learning test (revised) total word recall after 12 weeks
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
Secondary Outcome Measures
Mini mental state examination score
Clinical dementia rating (overall and sum of boxes)
CANTAB rapid visual information processing (RVIP) mean latency
CANTAB RVIP total correct hits
CANTAB spatial working memory within error, between error and strategy scores
Clinicians global impression of change
Disability assessment for dementia score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00130429
Brief Title
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease
Official Title
Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Phytopharm
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
dementia, memory, Hopkins verbal learning test, paired associated learning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PYM50028
Primary Outcome Measure Information:
Title
Hopkins verbal learning test (revised) total word recall after 12 weeks
Title
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
Secondary Outcome Measure Information:
Title
Mini mental state examination score
Title
Clinical dementia rating (overall and sum of boxes)
Title
CANTAB rapid visual information processing (RVIP) mean latency
Title
CANTAB RVIP total correct hits
Title
CANTAB spatial working memory within error, between error and strategy scores
Title
Clinicians global impression of change
Title
Disability assessment for dementia score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 50 years of age
Diagnosis of possible or probable Alzheimer's disease
Mini mental state examination score at least 16
Good understanding of both written and verbal English
A recent head scan that is consistent with the diagnosis of Alzheimer's disease
Exclusion Criteria:
Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
Known to have another condition that is associated with dementia
Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
Hormone replacement therapy started or changed within the previous 6 months
Received any investigational drugs within the previous 12 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Jacoby, FRCPsych
Organizational Affiliation
University of Oxford, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Project to Investigate Memory and Ageing
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
12. IPD Sharing Statement
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Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease
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