NCT00928304

Brief Summary

To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

2 active sites

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

June 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 28, 2014

Completed
Last Updated

March 5, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

June 24, 2009

Results QC Date

December 9, 2013

Last Update Submit

January 29, 2014

Conditions

Down SyndromeAmyloid Beta-protein

Keywords

Amyloid beta-proteinDown Syndrome

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome

    The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.

    100-120 min

Secondary Outcomes (3)

  • Sensitivity Results in the Down Syndrome Age Subgroups

    100 - 120 min

  • Quantitative Parameters Standard Uptake Value Ratio

    100 - 120 min p.i.

  • Consistency Between Visual and Quantitative Efficacy

    100 - 120 min

Study Arms (1)

Florbetaben (BAY94-9172)

EXPERIMENTAL
Drug: Florbetaben (BAY94-9172)

Interventions

Florbetaben (BAY94-9172)DRUG

300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Florbetaben (BAY94-9172)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study participants were individuals with DS and healthy volunteers (HVs).
  • \>=21 and \<= 40 years of age
  • Mini-Mental State Examination (MMSE) \>= 28
  • Clinical Dementia Rating (CDR) of 0
  • \>= 40 years of age

You may not qualify if:

  • Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Sun City, Arizona, 85351, United States

Location

Unknown Facility

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.

    PMID: 33773598DERIVED

MeSH Terms

Conditions

Down SyndromePlaque, Amyloid

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Juergen Hirschfeld
Organization
Piramal Imaging
juergen.hirschfeld@piramal.com
49 30 461 1246 15

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 5, 2014

Results First Posted

January 28, 2014

Record last verified: 2014-01

Locations

US(2)