NCT00130429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

First QC Date

August 12, 2005

Last Update Submit

August 20, 2009

Conditions

Alzheimer's Disease

Keywords

dementiamemoryHopkins verbal learning testpaired associated learning

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

PYM50028DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Project to Investigate Memory and Ageing

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

sarsasapogenin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Robin Jacoby, FRCPsych

    University of Oxford, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

January 1, 2004

Study Completion

September 1, 2005

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

GB(1)