Home » Current Enrolling Clinical Studies

Current Enrolling Clinical Studies

Cognitively Normal Individuals

Duke-UNC ADRC logoThe Duke University and the University of North Carolina Alzheimer’s Disease Research Center (Duke-UNC ADRC) brings together leading researchers in Alzheimer’s disease and related dementias across two major research institutions.

The ADRC aims to catalyze and support research, innovations in clinical care and academic work force development (with North Carolina Central University, East Carolina University and UNC Pembroke as partner institutions) in this field. The ultimate purpose is to reduce the burden of Alzheimer’s disease and related dementias regionally and nationally. The outstanding scientific environment at both institutions enables novel research to identify effective methods of prevention and/or early intervention, and to reduce racial and urban/rural disparities associated with dementia.

If you are interested in learning more about the study, please contact the Duke-UNC ADRC ORE Core at DukeUNC-ORECore@duke.edu.
The NC Registry for Brain Health is the first registry of its kind in the State of North Carolina. The Registry is designed to increase awareness of Alzheimer's disease and related disorders and to connect North Carolinians of all ages to research opportunities designed to improve brain health. When you join the NC Registry for Brain Health, you will learn about research taking place at Duke University, East Carolina University, North Carolina A&T State University, The University of North Carolina at Chapel Hill, and Wake Forest School of Medicine. All adults ages 18 or older are encouraged to join the registry.  When you join, you will receive a welcome email followed by a quarterly email newsletter which provides the most recent information about brain health research.  In addition, you will receive the occasional email which will provide you with information about a study opportunity. If you are interested in participating, you will contact the study coordinator listed in the email.  To learn more please go to: https://ncbrainhealth.org/  Enroll directly into the registry by following this link Or you can contact the NC Brain Health team at NCBrainHealth@duke.edu  or 919-613-8633
A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 (Lecanemab) in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial) Ages: 55-80 Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity less than (<) 65 years:
  • First degree relative diagnosed with dementia onset before age 75, or
  • Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or
  • Known before screening to have elevated brain amyloid according to previous PET or cerebrospinal fluid (CSF) testing
MMSE/MoCA: within normal limits CDR: 0 Diagnosis: normal cognition/subjective memory loss Additional relevant Inclusion/Exclusion Criteria:
  1. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening
  2. Hypersensitivity to any monoclonal antibody treatment
  3. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
  4. Bleeding disorder that is not under adequate control (including a platelet count 1.5) at screening
Contact: Kate Beck, kate.beck@duke.edu.

Enrollment Closed.

Every day, our dedicated team of researchers is working to find ways to prevent dementia, such as Alzheimer’s disease. We can’t do it alone. If you’re aged 65 and older, please volunteer for the PACT (Preventing Alzheimer’s with Cognitive Training) research study to see if computerized training exercises can reduce the risk of dementia. Study participation takes about three years and includes 3 study visits of up to 2 hours each. You will also complete 45 one-hour computer training sessions on your own, in your own home. You may qualify if you:
  • Are 65 years of age or older
  • Do not have any neurological disorders
  • Have not had a stroke or brain injury
  • Do not have mild cognitive impairment or dementia such as Alzheimer’s disease
Potential Benefits of Computerized Training Exercises Our research has shown that brain games may:
  • Protect against dementia such as Alzheimer’s disease
  • Enhance mental quickness and visual attention
  • Improve gait speed and balance
  • Improve driving safety
  • Maintain health and well-being
  • Allow you to perform everyday tasks more efficiently
  • Protect against depression
To see if you qualify, please call (919) 668-3154 or email us at: PACTstudy@duke.edu

Mild Cognitive Impairment or Alzheimer’s Disease

A 76-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia. Participants will receive study treatment via Intrathecal (IT) Injection every 12 weeks. Relevant Inclusion Criteria:
  • Age 50-80
  • Meets clinical criteria for Mild Cognitive Impairment (MCI) due to AD or mild AD dementia
  • Evidence of amyloid pathology as measured by PET or CSF sampling
  • MMSE 22-30
  • CDR 0.5-1
  • Have a reliable study partner who will attend designated study visits
Relevant Exclusion Criteria:
  • TIA, stroke, or unexplained loss of consciousness within 1 year of screening
  • History of seizures or epileptic syndrome within 10 years of screening
  • History of, or ongoing, malignant disease
  • History of bleeding disorder
  • Uncontrolled diabetes
  • Presence of clinically significant and/or unstable psychiatric illness
  • Significant findings on brain MRI and/or abnormal lab values
  • Presence of infection
  • Any major surgery within 12 weeks of screening
  • Use of any of the following medications within 30 days or 5 half-lives of the drug prior to the first dose and for the duration of the study:
    • a. Sensitive substrates for major CYP450 enzymes.
    • b. Strong inhibitors of major drug transporters.
    • c. Sensitive substrates of major drug transporters.
Contact study coordinator Amy Obssi, Amy.Obssi@duke.edu, for more information.
To enroll in this study or for more information, please contact Amy Obssi at amy.obssi@duke.edu. This study is for people diagnosed with mild cognitive impairment. It tests the content and usability of the VRFACT, a performance-based measure of functional capacity. Participants come to the office and use the VRFACT on an electronic tablet to complete several real life scenarios. Inclusion Criteria:
  • Men or women, 55 - 85 years of age
  • Ability to speak and read English fluently
  • Clinical diagnoses for mild cognitive impairment (MCI) as operationalized below and supported with biomarkers
    • Diagnosis of MCI by standard diagnostic evaluation
    • Affirmed with CSF biomarker testing
  • Patients must have a caregiver or appropriate informant available
  • Patients must consent to the audio recording of the study interviews
Exclusion Criteria:
  • Patients who are experiencing any acute or chronic medical illness that would substantially diminish their ability to participate in an interview study (e.g., documented neurological disorder) or interfere with daily functioning.
  • Patients who present as intoxicated on the day of assessment
  • Patients with severely limited eyesight and/or hearing based on investigator judgment will be excluded (since the study involves completing the VRFCAT on a tablet and participating in an interview).

Closed to enrollment. 

By using an iPhone and Apple Watch, this study is evaluating how devices may be able to help measure thinking and memory changes in adults with mild cognitive impairment. If you do not have an Apple Watch, the study will provide one!  Participants in this study are asked to download a mobile app and wear an Apple Watch during their daily activities. The mobile app includes cognitive games and questionnaires once a month while the Apple Watch tracks daily data like heart rate and step count.  Eligible participants must: 
  1. Have a diagnosis of “Mild Cognitive Impairment” or “MCI” and have had a medical and neurological evaluation in the last 24 months 
  2. Own an iPhone 8, or newer model, and are willing to wear an Apple Watch every day 
  3. Are 21-86 years of age, fluent in English, and have at least 8 years of education 
  4. Have access to a computer and internet 
  5. Have an email address, telephone number, and primary address within the US (not a PO box)
Please contact Luigi Troiani troianil@neurology.unc.edu +1 (919) 843-2579 to learn more about the study. 

Closed to enrollment. 

A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (ACT-AD), a randomized, double-blind, placebo-controlled, parallel-group 26-week trial evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease. ATH-1017 is designed to enhance synaptic activity. Sub-cutaneous injection.   MMSE/MoCA: MMSE 14-24 Diagnosis: dementia, due probably to AD Additional relevant Inclusion/Exclusion Criteria:
  • Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
  • Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
    • Treatment-naïve, OR
    • Subjects who received continuous dosing for at least 6 months, and are on a stable, approved dose of an AChEI for at least 3 months before Screening OR
  • Renal insufficiency (serum creatinine > 2.0 mg/dL)
  • Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
  • Malignant tumor within 3 years before Screening
  • Memantine (Namenda®) and combination product of donepezil and memantine product (Namzaric®) within 6 weeks prior to Screening

Closed to enrollment.

The Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia Oral Health is evaluating an intervention to help individuals with mild dementia improve and maintain the health of their teeth and mouth. The study involves 3 home visits over 6 months. The participant and their study partner will learn about good oral hygiene habits, and a dental hygienist will evaluate the participant’s teeth and gums. Participants will receive an electronic toothbrush and both the participant and study partner will receive financial compensation. Eligible participants must:
  • Have at least 4 natural teeth
  • Have a family member or friend who lives with them and is willing to be their study partner
  • Be at least 60 years of age
  • Have a diagnosis of mild dementia
  • Speak and understand English
Please contact Cappye Mott at Catharine.Mott@duke.edu or 919-668-2420 to learn more about the study. Pro 0010106

Closed to enrollment.

This clinical trial is an open label, dose-ranging study designed to evaluate gene therapy to treat patients who are APOE4 homozygotes with clinical diagnosis varying from mild cognitive impairment due to Alzheimer's, mild dementia due to Alzheimer's disease, and moderate dementia due to Alzheimer's disease. Find out more here.

Closed to enrollment.

A 12-Week Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants with Mild-to-Moderate Alzheimer’s Disease (AD). Buntanetap will be provided in the form of an oral capsule. Relevant Inclusion Criteria:
  • Diagnosis of AD
  • Age 55-85
  • MMSE 14-24
  • Have a reliable study partner who will attend all study visits with the participant
Relevant Exclusion Criteria:
  • History of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression
  • Non-AD Dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, Parkinson’s disease dementia, or B12 and thyroid deficiency-caused dementia
  • History of seizure disorder (acceptable if on stable meds)
  • Uncontrolled Type 1 or Type 2 diabetes
  • Has cancer or has had a malignant tumor within the past year
Use of the following medications is allowed if participants have been stabilized for at least 4 weeks before screening and will continue to be stable throughout the study:
  • Tricyclic antidepressants
  • Antipsychotics prescribed for any reason (some exclusions apply)
  • Psychostimulants

Frontotemporal Dementia

ALLFTD is a multisite observational research study aimed at understanding how frontotemporal lobar degeneration (FTD or FTLD) syndromes affect the brain. This research study has a longitudinal option, consisting of one study visit a year (including fasting blood draw, cognitive testing, clinical assessment, questionnaires, MRI brain imaging and optional lumbar puncture and genetic testing) for up to five years, and a biofluid option, which is a shorter one-time visit. Frontotemporal degeneration syndromes may include behavioral variant FTD (bvFTD), Progressive Supranuclear Palsy (PSP), semantic variant or nonfluent variant primary progressive aphasia (svPPA or nfvPPA), or FTD with Amyotrophic Lateral Sclerosis (FTD/ALS). To be eligible for the study, you must:
  1. Have a referring diagnosis of an FTLD clinical syndrome, be a member of a family with a strong medical history of an FTLD syndrome, or have a known genetic mutation associated with FTD.
  2. Have a reliable study partner who you talk with at least once a week
If you are interested in learning more about the study, please email us at ALLFTD@neurology.unc.edu or call us at 919-843-8673. You can also learn more at the ALLFTD website, https://www.allftd.org/.

This trial is closed for enrollment. 

Transposon Therapeutics, Inc. is investigating the safety and tolerability of TPN-101, an oral medication, in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) associated with a mutation in the C9orf72 gene. Eligible participants have a 60% chance of receiving TPN-101 and a 40% chance of receiving placebo (sugar pill) during the 24-week double-blind treatment period and a 100% chance of receiving TPN-101 during the subsequent 24-week open-label treatment period. 
To be eligible for this 58-week (1.1 year) study, you must:
  1. Have the C9orf72 mutation as confirmed by clinical genetic testing  
  2. Have a caregiver/study partner accompany you at all visits
  3. Be on stable doses of all other medications for 1 month prior to screening
  4. Be diagnosed with ALS and/or FTD
Please contact study coordinator Victoria Banks at Victoria_Banks@neurology.unc.edu or (919) 962-5137 if you are interested in participating.

Lewy Body Disease

If you are interested in learning more about the study, please contact our study coordinator Victoria Banks at Victoria_Banks@neurology.unc.edu or (919)962-5137. An oral medication, CT1812, is being investigated for the potential treatment of Dementia with Lewy Bodies (DLB). The purpose of this clinical trial is to learn about the safety of CT1812 and how well your body tolerates a once-a-day dose of CT1812. The study will also test how well CT1812 treats symptoms of mild to moderate DLB. Eligible participants will have a 2 out of 3 (66.6%) chance of receiving CT1812 and a 1 out of 3 (33.3%) chance of receiving placebo (sugar pill).
To be eligible for the 6-month study, the following criteria must be met:
  • Must have a caregiver/ study partner 
  • Willingness to undergo a lumbar puncture (LP) during the screening period and at the end of the 6-month treatment period.
  • Formal education of eight or more years.
  • Reside at home or in an assisted living facility.
  • Must be able to complete all screening evaluations
  • Must be between the ages of 50 and 85 and have a diagnosis of Dementia with Lewy Bodies. 
DLBC is an observational research study aimed at learning more about Dementia with Lewy Bodies. The trial focuses on identifying biomarkers associated with the disease. DLBC consists of one research visit approximately once a year for up to 5 years, which includes a lumbar puncture or spinal tap, fasting blood draw, brain imaging (MRI and DaTScan), cognitive testing, a clinical assessment, and questionnaires.  To be eligible for the study, you must:
  1. Have a diagnosis or probable Dementia with Lewy Bodies, Dementia with Lewy Bodies with mild cognitive impairment (MCI), or Parkinson’s disease dementia
  2. Have a study partner who is willing to participate in required study procedures 
  3. Have at least 8 years of education.
For questions or to participate in the study, please email us at DLBC@neurology.unc.edu or call us at 919-843-8673. Learn more about Lewy Body Dementia here: UNC Neurology, Lewy Body Dementia

Additional resources for finding research opportunities:

  1. Alzheimers.Gov
  2. Duke Neurology – Clinical Trials
  3. UNC Neurology – Clinical Trials