NCT01867359

Brief Summary

Background: \- Researchers are interested in learning more about dementia and its causes. They want to look at the genetic basis of dementia. Identifying genetic aspects of dementia may help provide better tests and treatments for it. It may also show rare gene variants that can cause or alter a person's risks for developing dementia. This study will look at people who have dementia, their family members, and healthy volunteers. Objectives: \- To study genetic influences on dementia. Eligibility:

  • Individuals who have been diagnosed with dementia.
  • Family members of individuals who have been diagnosed with dementia.
  • Healthy volunteers at least 18 years of age. Design:
  • Participants will be interviewed and answer questions about their medical history. They will also provide general information on the relatives' medical histories.
  • Participants will provide a blood sample for genetic testing.
  • Participants will remain on the study for up to 10 years. They will have regular visits to monitor their brain health and function.
  • Treatment will not be provided as part of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

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

March 14, 2003

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed
Last Updated

April 5, 2018

Status Verified

September 20, 2016

Enrollment Period

13.5 years

First QC Date

May 29, 2013

Last Update Submit

April 4, 2018

Conditions

Keywords

Alzheimer DiseaseMolecularMolecular GeneticsDNA

Outcome Measures

Primary Outcomes (1)

  • Genetic cause of disease identified

    Once every 12-24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of Dementia by neurologist, other medical care provider, or researcher accompanied by sufficient clinical and/or laboratory evidence
  • Clinical confirmation of Dementia by the investigator and his associates either by exam and/or review of medical records
  • Family member of diagnosed dementia patient
  • Healthy controls

You may not qualify if:

  • Individuals with any movement disorder secondary to a specific environmental exposure, birth injury, metabolic disorder, or brain infection such as encephalitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Andrew Singleton, Ph.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 4, 2013

Study Start

March 14, 2003

Primary Completion

September 20, 2016

Study Completion

September 20, 2016

Last Updated

April 5, 2018

Record last verified: 2016-09-20

Locations