NCT03702907

Brief Summary

The Georgetown University Memory Disorders Program, part of the Department of Neurology, is conducting pilot studies of the feasibility of various diagnostic tests for Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. Further, this study is assessing longitudinal changes in biological, lifestyle, and cognitive assessment collection. The primary goal of this study is to examine the feasibility of biochemical assays, genetic testing, and cognitive and lifestyle assessments in the ante-mortem diagnosis of Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. This research involves genetic and cognitive status testing but the findings will not be shared with research subjects. This will be accomplished ex vivo using blood, and/or cerebrospinal fluid (CSF) specimens from patients with a diagnosis of probable Alzheimer's disease, mild cognitive impairment, or other neurodegenerative diseases and from normal controls.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
Jan 2007Jan 2027

Study Start

First participant enrolled

January 1, 2007

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

20 years

First QC Date

October 9, 2018

Last Update Submit

October 23, 2019

Conditions

Keywords

Frontotemporal DementiaLewy Body DementiaAgingVascular Dementia

Outcome Measures

Primary Outcomes (1)

  • CDR

    Clinical Dementia Rating

    9 years

Study Arms (2)

Normal Cognition

No diagnosis of a cognitive disorder

Cognitive Disorder

Diagnosed with a cognitive disorder such as :Mild Cognitive Impairment, Alzheimer's disease, Frontotemporal Dementia, Lewy Body Dementia, Vascular Dementia, or other neurodegenerative condition.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All genders, races, and ethnicities eligible. Normal controls and those diagnosed with a neurodegenerative disorder eligible.

You may qualify if:

  • Age 45 and older.
  • Subjects within the age range of 45-50 years old must have a first degree relative with a neurodegenerative disease.

You may not qualify if:

  • Individuals under 45 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Memory Disorders Program

Washington D.C., District of Columbia, 20057, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Collection of Blood Collection of Cerebrospinal Fluid (CSF) (Optional)

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive DysfunctionFrontotemporal DementiaLewy Body DiseaseDementia, Vascular

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 11, 2018

Study Start

January 1, 2007

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

October 24, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations