Study for Early-Onset Alzheimer's Disease

(LEADS Trial)

Recruiting at 26 trial locations

Overseen By IU LEADS Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Investigational agents, Anticoagulants

Disqualifiers: Non-AD dementia, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand early-onset Alzheimer's disease by observing its progression over time. Participants will undergo various assessments, including cognitive tests and brain scans, to gather data on their condition. The study includes three groups: those with early-onset Alzheimer's, those with early-onset cognitive issues not related to Alzheimer's, and those with normal cognitive function. Individuals diagnosed with early-onset memory or thinking problems, or those who are cognitively normal and between 40-64 years old, might be a good fit. This research will not provide any treatment but will help inform future therapies. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could shape future treatments for early-onset Alzheimer's.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, investigational agents are not allowed 30 days before joining the study, and certain medications may be restricted for optional procedures. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Florbetaben and Flortaucipir, both used in PET scans for Alzheimer's research, are generally safe. Florbetaben detects amyloid plaques in the brain. Some individuals have reported mild side effects like headaches or dizziness, but it is usually well-tolerated. Flortaucipir scans identify tau protein build-up, another Alzheimer's indicator. Studies have demonstrated its accuracy in identifying patients with high tau levels, and no serious side effects were commonly reported.

Both have undergone testing in various studies and are considered safe enough for trials. However, like any medical procedure, a small risk of side effects exists. Prospective participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Longitudinal Early-onset Alzheimer's Disease Study Protocol because it aims to deepen our understanding of how Alzheimer's develops in its early stages. Unlike current treatments that primarily focus on managing symptoms, this study uses advanced imaging techniques like florbetaben and flortaucipir PET scans to track amyloid and tau protein buildup in the brain. This approach could lead to earlier and more accurate diagnosis, potentially opening the door to better-targeted treatments in the future. By studying different groups, including those with and without Alzheimer's, the trial could uncover crucial differences in disease progression and cognitive function, paving the way for breakthroughs in early intervention strategies.

What evidence suggests that this trial's treatments could be effective for early onset cognitive impairment?

In this trial, participants will undergo various PET scans to study Alzheimer's disease and related conditions. Research has shown that florbetaben, used in some trial arms, aids in understanding Alzheimer's by predicting progression through the detection of amyloid plaques, sticky protein clumps linked to the disease. Studies indicate that florbetaben PET scans can differentiate early-onset Alzheimer's from other conditions by identifying these amyloid markers. Meanwhile, flortaucipir, used in other trial arms, detects tau protein tangles, another sign of Alzheimer's. Flortaucipir PET scans have demonstrated high accuracy in identifying Alzheimer's patterns, with both sensitivity and specificity around 90%. These scans provide valuable insights into how Alzheimer's develops and progresses, aiding in early diagnosis and understanding. ^{3 6 7 8 9}

Who Is on the Research Team?

Liana Apostolova, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

Meets NIA-AA criteria for MCI due to AD or probable AD dementia

Have a global CDR score ≤ 1.0

Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial clinical and cognitive assessments, including biomarker and genetic tests, PET and MRI brain scans

1 month

1 visit (in-person)

Longitudinal Assessment

Participants undergo repeated clinical and cognitive assessments, biomarker and genetic tests, and brain scans over the study period

24-48 months

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in cognition and other health parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Florbetaben
• Flortaucipir
• Fluorodeoxyglucose

How Is the Trial Designed?

Group I: Early Onset non-Alzheimer's Disease (EOnonAD) Experimental Treatment 3 Interventions

* Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia * Amyloid negative status (florbetaben PET scan with no evidence of elevated amyloid as determined by a central read) * CDR score ≤ 1.0 * flortaucipir (18F-AV-1451) PET scanning

Group II: Early Onset Alzheimer's Disease (EOAD) Experimental Treatment 2 Interventions

* Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia * Amyloid positive status (florbetaben PET scan with evidence of elevated amyloid as determined by a central read) * CDR score ≤ 1.0 * flortaucipir (18F-AV-1451) PET scanning

Group III: Cognitively Normal (CN) Controls Experimental Treatment 3 Interventions

* Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions and activities of daily living * Mini-Mental State Exam score between 26-30 * CDR score = 0 * flortaucipir (18F-AV-1451) PET scanning

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Liana Apostolova

Lead Sponsor

Trials

1

Recruited

850+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Alzheimer's Therapeutic Research Institute

Collaborator

Trials

18

Recruited

58,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37238154/

A Case Report of Early-Onset Alzheimer's Disease Using ... We describe a 40-year-old female patient who presented with sleep disturbance, intermittent headache, and gradual subjective cognitive decline.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03507257

Longitudinal Early-onset Alzheimer's Disease Study ... The primary objectives of the LEADS study are to: collect longitudinal assessments and biomarker data in individuals with early onset cognitive impairment (EOAD ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1552526017337639

Added value of 18F-florbetaben amyloid PET in the ... This multicenter study was performed at French tertiary memory clinics in patients presenting with most complex clinical situations.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485979/

18F PET with florbetaben for the early diagnosis of ... Review question: In people with mild cognitive impairment (MCI), does using a 18F PET scan with florbetaben predict progression to Alzheimer's disease dementia ...

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13453

Amyloid and tau‐PET in early‐onset AD: Baseline data from ... Florbetaben scans were used to distinguish cognitively impaired participants with EOAD (Aβ+) from EOnonAD (Aβ−) based on the combination of ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/174057

Longitudinal Early-onset Alzheimer's Disease Study Protocol An approximately 30-minute image acquisition scan will be performed. Drug. Florbetaben. All participants will receive a single bolus intravenous ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03507257

Longitudinal Early-onset Alzheimer's Disease Study Protocol Amyloid negative status (florbetaben PET scan with no evidence of elevated amyloid as determined by a central read); CDR score ≤ 1.0; flortaucipir (18F-AV ...

8. mdpi.com mdpi.com/2075-4418/13/10/1671

A Case Report of Early-Onset Alzheimer's Disease Using ... We describe a 40-year-old female patient who presented with sleep disturbance, intermittent headache, and gradual subjective cognitive decline.

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12350

The Longitudinal Early‐onset Alzheimer's Disease Study ... Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study. Alzheimers Dement. 2015; 11(8): 964-974 ...