NCT01094340

Brief Summary

This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

March 25, 2010

Last Update Submit

August 6, 2012

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Improve cognition

    2 years

Study Arms (1)

Thalidoide

OTHER

CSF

Drug: Thalidomide

Interventions

ThalidomideDRUG

fixed dose over 8 clinic visits

Also known as: Celegene
Thalidoide

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
  • Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
  • Subject must live at home.
  • Must have a caregiver to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Carolyn Liebsack, BSN

    Banner Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MARWAN SABBAGH, MD Director

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

US(1)