Safety and Effect on Memory of PYM50028 in Mild Alzheimer... | NCT00130429

Studies
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease

NCT00130429

Sponsor

Phytopharm

Status

Completed

Last Update Posted

Aug 21, 2009Estimated

Enrollment

250

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

PYM50028

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Sep 2005Actual

First Submitted Date

Aug 12, 2005

First Submission Date that Met QC Criteria

Aug 12, 2005

First Posted Date

Aug 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2009

Last Update Posted Date

Aug 21, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Name	Type	Description	Arm Group Labels	Other Names
PYM50028	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mini mental state examination score
Clinical dementia rating (overall and sum of boxes)
CANTAB rapid visual information processing (RVIP) mean latency

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robin Jacoby, FRCPsych	University of Oxford, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford Project to Investigate Memory and Ageing		Oxford	Oxfordshire	OX3 7JX	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C046297	sarsasapogenin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided