NCT05923307

Brief Summary

The goal of this observational study is to assess the role of narcisistic personality disorder and life stressful events in conversion rate to dementia, using a three tier approach along three research lines employing subjects with dementia in retrospective assessment, and normal subjects no yet developing demetia in prospective follow up. The main question\[s\] it aims to answer are:

  • narcisistic personality disorder as risk factor for conversion to dementia
  • life stressful events as risk factor for conversion to dementia Participants will be assessed with a complete neurocognitive battery, brain images studies, laboratory analysis, and sociodemographic profile, including depression and comorbidities.

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
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

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

May 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 19, 2023

Last Update Submit

July 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • new onset of dementia during the follow-up period

    dementia diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders V, considered affected by dementia when agreement on this diagnosis was reached between a psychologist and a geriatrician. If the physicians failed to agree, the diagnosis had to be confirmed by a second geriatrician.

    1 year

Secondary Outcomes (1)

  • univariate proportional hazard ratios for narcissistic personality as risk factor, adjusted for age and sex

    1 year

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals eligible to participate were diagnosed with dementia, or had inconclusive results living at the community or residential institutions invited to attend a follow-up, cognitively healthy or minimally impaired, or had mild cognitive impairment (MCI), or dementia

You may qualify if:

  • research line 3
  • healthy subjects over 50 years of age.
  • diagnosis of dementia should be made according to DSM V criteria.
  • Diagnoses made by operationalised criteria for dementia

You may not qualify if:

  • Participants excluded if declined participation, died or withdrew from the study
  • unable to perform the assessments due to other co-morbid conditions
  • were too visually impaired to complete cognitive assessments.
  • putative narcisistic personality disorder
  • no age limit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

universidad Atlantida

Buenos Aires, Outside U.S. and Canada, 1405, Argentina

RECRUITING

Related Publications (5)

  • Fiest KM, Jette N, Roberts JI, Maxwell CJ, Smith EE, Black SE, Blaikie L, Cohen A, Day L, Holroyd-Leduc J, Kirk A, Pearson D, Pringsheim T, Venegas-Torres A, Hogan DB. The Prevalence and Incidence of Dementia: a Systematic Review and Meta-analysis. Can J Neurol Sci. 2016 Apr;43 Suppl 1:S3-S50. doi: 10.1017/cjn.2016.18.

  • Ganguli M, Dodge HH, Chen P, Belle S, DeKosky ST. Ten-year incidence of dementia in a rural elderly US community population: the MoVIES Project. Neurology. 2000 Mar 14;54(5):1109-16. doi: 10.1212/wnl.54.5.1109.

  • serrani daniel Narcissism Vulnerability as Risk Factor for Alzheimer´s Disease- A Prospective Study Austin J Clin Neurol 2015;2(7): 1057.

    RESULT
  • Chatterjee A, Strauss ME, Smyth KA, Whitehouse PJ. Personality changes in Alzheimer's disease. Arch Neurol. 1992 May;49(5):486-91. doi: 10.1001/archneur.1992.00530290070014.

  • Wilson RS, Schneider JA, Arnold SE, Bienias JL, Bennett DA. Conscientiousness and the incidence of Alzheimer disease and mild cognitive impairment. Arch Gen Psychiatry. 2007 Oct;64(10):1204-12. doi: 10.1001/archpsyc.64.10.1204.

MeSH Terms

Conditions

Pick Disease of the BrainNarcissistic Personality DisorderDepression

Condition Hierarchy (Ancestors)

Frontotemporal DementiaFrontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPersonality DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal researcher

Study Record Dates

First Submitted

June 19, 2023

First Posted

June 28, 2023

Study Start

May 20, 2023

Primary Completion

April 20, 2024

Study Completion

September 20, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations