NCT05989087

Brief Summary

The literature suggests a strong association between amyloid accumulation and gamma alterations, emerging gamma activity as a biomarker candidate for Alzheimer's pathology. The present study aims to investigate resting-state gamma activity changes in Cerebrospinal fluid (CSF)-proven early-onset Alzheimer's disease (EOAD) patients with a holistic approach that employs structural and functional brain neuroimaging techniques, and neuropsychological aspects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2016

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

July 25, 2023

Last Update Submit

August 17, 2023

Conditions

Alzheimer Disease, Early Onset

Keywords

Alzheimer's diseaseGamma activityResting-state EEGDiscriminative powerMRI

Outcome Measures

Primary Outcomes (1)

  • EEG

    The resting state EEG recordings were acquired using Easy-Cap comprising 30 Ag/AgCl electrodes placed according to the international 10-20 system. Coherence and maximum peak power of the total gamma (30-48 Hz) and sub-gamma bands \[gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz)\] were measured for each participant.

    Day 2

Secondary Outcomes (3)

  • Correlation Analysis

    3 months

  • Discriminant Analysis

    3 months

  • MRI

    Day 1

Study Arms (2)

Early-onset Alzheimer's disease

Patients were recruited from the outpatient memory clinics of the Department of Neurology, Dokuz Eylül University Hospital. The patient group was diagnosed by an expert neurologist, according to the National Institute on Aging-Alzheimer's Association diagnostic criteria for Alzheimer's disease

Diagnostic Test: CSF

Healthy controls

Age-and gender-matched healthy volunteers were recruited via advertisements and word-of-mouth.

Interventions

CSFDIAGNOSTIC_TEST

Early-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests.

Also known as: MRI, Neuropsychological tests
Early-onset Alzheimer's disease

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The present study included a retrospective investigation of EEG and MRI data. The total sample for the study consisted of 24 early-onset Alzheimer's disease patients and 24 healthy controls.

You may qualify if:

  • For all participants: Age \< 65
  • For EOAD patients: Meeting National Institute on Aging-Alzheimer's Association diagnostic criteria.
  • For healthy controls: Mini-Mental State Examination (MMSE) \>25 Instrumental Activities of Daily Living Scale (IADL) = 8

You may not qualify if:

  • For EOAD patients: MMSE \> 24 Geriatric depression scale (GDS) \> 14 Having treatment with antipsychotics and comorbidities that may affect cognitive abilities.
  • For healthy controls: Having neurological and/or cognitive abnormalities Having a history of neurological, psychiatric, or systemic disorders, and alcohol/drug abuse. GDS \> 14
  • For all participants: Having neurological (other than AD) or any other serious disease (cancer, systemic disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir University of Economics

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 14, 2023

Study Start

November 7, 2012

Primary Completion

January 2, 2016

Study Completion

April 5, 2019

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

TU(1)