Brain NAD in Alzheimer's Disease | NCT07127510

Studies
Brain NAD in Alzheimer's Disease

NCT07127510

Sponsor

Florida Atlantic University

Status

Recruiting

Last Update Posted

Mar 24, 2026Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Alzheimer Disease (AD)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2026Actual

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Aug 11, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the levels of nicotinamide adenine dinucleotide (NAD) in the brains of people with Alzheimer's disease. The study aims to determine if brain NAD levels are lower in people with Alzheimer's disease compared with people of the same age group who do not have Alzheimer's disease.

Participants with or without Alzheimer's disease will have a brain imaging session where NAD will be measured using magnetic resonance spectroscopy (MRS). Eight months later, they will have a second, similar, brain imaging session.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alzheimer's disease group		People diagnosed with Alzheimer's disease
Control group		People without Alzheimer's disease

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain NAD	NAD levels measured by 1H-MRS	At enrollment and 8 months after enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants are able to come to the Florida Atlantic University Clinical Research Unit, are verbal and ambulatory.
Age 65 to 80 included.
People with Alzheimer's disease (AD): AD diagnosis established by the person's physician according to the following criteria: clinical diagnosis AND either positive amyloid PET-scan or FDA-approved positive CSF or blood test.

Exclusion Criteria:

Under the age of 65 or over the age of 80.
Advanced dementia such that the person would require sedation for undergoing an MRI scan.
Receiving anti-amyloid intravenous treatments Leqembi or Kinsula.
Having an MRI-incompatible pacemaker or other MRI-incompatible hardware (e.g. comprising a metallic part).
Having a history of seizures.
Working at night.
Having cancer or having been diagnosed with cancer within the last 5 years (excluding superficial squameous or basal cell cancer).
People with no AD: MoCA test result lower than 26.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Primary care clinic, community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
FAU Clinical Research Unit Central Contact	Contact	561-235-4467		CRUDOR@health.fau.edu

Overall Officials

Name	Affiliation	Role
Corinne Lasmezas, PhD	Florida Atlantic University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FAU Clinical Research Unit	Recruiting	Boca Raton	Florida	33431	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Primary outcome measure data will be shared.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

IPD and supporting information will be available from June 2027 to Mai 2028.

Access Criteria

The type of analyzes qualifying for data sharing will be those submitted for publication. After publication these data will be freely available. Before publication, a proposal describing planned analyses must be submitted to FAU Office of Research Integrity via the contact information available on the website, and a data sharing agreement must be signed between FAU and the receiving party.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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