Brain NAD in Alzheimer's Disease

NCT07127510 | Recruiting

• 1 other identifier: IRB2504137
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease (AD)

Keywords

NAD; Alzheimer Disease (AD)

Outcome Measures

Primary Outcomes (1)

• Brain NAD

  NAD levels measured by 1H-MRS

  At enrollment and 8 months after enrollment

Study Arms (2)

Alzheimer's disease group

People diagnosed with Alzheimer's disease

Control group

People without Alzheimer's disease

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, community.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida Atlantic University: lead

Study Sites (1)

FAU Clinical Research Unit

Boca Raton, Florida, 33431, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and urine

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Corinne Lasmezas, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FAU Clinical Research Unit Central Contact

CONTACT

561-235-4467; CRUDOR@health.fau.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)