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Columbia University
Irving Medical Center
Neurological Institute

710 West 168th Street, 3rd floor
(212) 305-1818

Clinical Trials

Clinical Trials Currently Recruiting (April 2025)

Mild Cognitive Impairment/Early Onset Alzheimer's Disease Synaptic Therapy Alzheimer's Research Trial (START)
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
ClinicalTrials.gov ID NCT05531656. Sponsor Cognition Therapeutics, Inc.
Phase 2: Oral Medication. Once Daily. Duration: approximately 18 months (72 weeks). MCI due to AD or mild AD.
MMSE 20-30, CDR 0.5-1.0 Age: 50-85 Procedures Include: MRIs, Confirmation of Amyloid via PET or CSF biomarkers consistent with AD, sample collection.
Anti-amyloid therapies permitted if on treatment for 6 months or longer.
(Dr. Bell) Call: Brittney Paniagua 212-305-7661

UPCOMING: Mild Cognitive Impairment/Early Onset Alzheimer’s Disease: Focused UltraSound (NIA)
Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound
ClinicalTrials.gov ID NCT06600880.
Phase 1B. Duration:5 visits.
Amnestic Mild Cognitive Impairment/Alzheimer’s Disease. MMSE: 12-26. Age: ≥50.
Procedures include: MRI, Amyloid PET scan, Tau PET Scan, focused ultrasound treatment
(Dr. Mintz/Dr. Honig/Dr. Konofagou) Call Sergio Jimenez-Gambin 212-342-1612

Progressive Supranuclear Palsy (PSP) PROSPER
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)
ClinicalTrials.gov ID NCT06355531. Sponsor: Ferrer Internacional S.A.
Phase 2 Oral Medication. Duration: 62 weeks. Age: 50-80. MoCa score: ≥ 23. Procedures include: MRI, optional LP’s for a substudy.
(Dr. Honig) Call Katrina Causay 212-305-2077

Cerebral Amyloid Angiopathy (CAA) (cAPPricorn-1)
A study of ALN-APP in Patients with Cerebral Amyloid Angiopathy (CAA)
ClinicalTrials.gov ID NCT06393712. Sponsor: Alnylam Pharmaceuticals, Inc.
Phase 2. Drug is administered by lumbar puncture every 6 months over 18 months.
Duration: 24 months and an optional 18-month open label, additional 12-month safety follow up. Age: CAA patients ≥50 years of age, D-CAA patients ≥30 years of age. MMSE: ≥22, CDR: 0-1, Procedures include: MRIs and LPs.
(Dr. Honig) Call Katrina Causay 212-305-2077

Early Age-Related Hearing Loss Investigation: EARHLI, (NIH/NIA)
A study to determine the effect of hearing intervention vs. health education comparator intervention on cognitive performance, social engagement, and brain organization/connectivity in adults with Amnestic MCI and Hearing Loss.
ClinicalTrials.gov ID NCT06174038.
Phase 2: Hearing Aid vs. Health Education Comparator, Duration: 52 weeks.
Subjective Cognitive Complaint /Amnestic MCI, Borderline to Moderate Hearing Loss CDR memory score: 0.5. Age: 55 - 75 years. Participants get free hearing aids by the study end.
Procedures include: Hearing test, MRI (half the participants) blood test: pTau, APOE.
(Dr. Justin Golub) Call Jesus Lopez 646-317-3252, email: earhli@cumc.columbia.edu

Alzheimer’s Disease: KAR-031 (Karuna Therapeutics)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease Dementia.
ClinicalTrials.gov ID NCT05511363.
Phase 3. Oral Medication. 3x Daily. Duration: about 44 weeks.
MMSE = 8–22. Age: 50-90.
Procedures include: Cognitive Assessments; Blood Draws.
(Dr. Devanand) Call Memory Disorders Clinic: Lola Nedic 646-774-720, email: ln2563@cumc.columbia.edu

Mild Cognitive Impairment (COGIT-2 Trial)
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial.
ClinicalTrials.gov ID NCT06601933.
A study comparison of 4 crossword puzzles per week (high dose arm), 1 crossword puzzle per week (low dose arm), or health education.
MCI. MOCA score ≥ 20. Age: 55 to 89 years old. Duration: 78 weeks, 5 in person visits. Procedures: Blood draws, MRIs. Anti-amyloid therapies are not permitted during the study.
(Dr. Devanand) Call: Meaghan Janis: 646-774-8641 email: mmj2176@cumc.columbia.edu OR Lola Nedic: 646-774-7202 email: ln2563@cumc.columbia.edu

Observational Studies Currently Recruiting (April 2025)

Mild Cognitive Impairment/Alzheimer’s Disease/ Normal Cognition: ADRC clinical core (NIH/NIA)
Alzheimer’s Disease Research Center Clinical Core
Duration: 2 hours visit (in person). Visits are every year for the duration of the study.
Mild Cognitive Impairment/Mild Alzheimer’s Disease/Normal Cognition. Age: 55-90.
Procedures include: MRI, LP.
(Dr. Noble) Call Naara Ramirez Estevez 212-305-9971

UPCOMING: Mild Cognitive Impairment/Alzheimer’s Disease/ Normal Cognition: CLARiTI (NIH/NIA)
ADRC Consortium for Clarity in ADRD Research Through Imaging
Duration: 2 years, baseline visits and 2 year follow up.
CDR 0, 0.5, or 1; Age: ≥ 50; must co-enroll with ADRC
Procedures include: Blood draw, MRI, Amyloid, and Tau PET scans
(Dr. Lao) Call Anna Smith 212 305-1625

Alzheimer’s Disease Neuroimaging Initiative 4 (ADNI4)
(USC.EDU/NIA)
ClinicalTrials.gov ID NCT05617014.
Duration: 5 years. Age: 55-90 years Cognitively Normal, Mild Cognitive Impairment, and AD.
MMSE: 20-30, CDR: 0-1.0 Procedures: MRI, amyloid PET, Tau PET, optional LP. Anti amyloid therapies permitted.
(Dr. Honig) Call Jee Min Kim 212 305- 5805 or Katrina Causay 212 305-2077

Mild Cognitive Impairment/Early Onset Alzheimer’s Disease/Normal Cognition: LEADS (NIH/NIA)
Longitudinal Early Onset Alzheimer’s Disease Study
ClinicalTrials.gov ID NCT03507257.
Duration: 4 years, yearly visit. Mild Cognitive Impairment/Early Onset Alzheimer’s Disease. CDR: 0.5 or 1.0. Age: 40-64.
Procedures include MRI, Amyloid PET, Tau PET, optional LP. Optional genetic results. Anti amyloid therapies permitted.
(Dr. Honig) Call Arlene Mejia 212-305-9168

Healthy Volunteers with Cognitive Complaints: Diverse VCID (NINDS)
Diverse Vascular Contributions to Cognitive Impairment and Dementia
Duration: 3 years, yearly visit Subjective memory complaints, stroke free, CDR 0 or 0.5; Age: 65-90; must co-enroll with ADRC
Procedures include: fasting blood draw, structural MRI, lifestyle questionnaires, list learning task
(Dr. Brickman) Call Christiane Hale 646-317-4072

Mild Alzheimer's Disease/Normal Cognition: AD Autoimmune (NIH/NINDS)
Autoimmune features in neurodegenerative disorders
ClinicalTrials.gov ID NCT04239079.
Duration: 1 to 2 visits. 1.5hrs per visit. Mild Alzheimer's Disease/Amnestic Mild Cognitive Impairment/Normal Cognition. AD: MMSE: 18-26, CDR 0.5-1. Age: ≥55.
Procedures include: 100ml blood draw.

Amnestic, visual, and language variants of Mild Cognitive Impairment/AD: ADVISe (NIH/NIA)
Longitudinal imaging of microglial activation in different clinical variants of Alzheimer's disease
ClinicalTrials.gov ID NCT04576793.
Duration: 2 years, baseline visits and 2 year follow up. Amnestic Mild Cognitive Impairment/Amnestic Alzheimer's Disease/Posterior Cortical Atrophy/Logopenic Variant Primary
Progressive Aphasia/Normal Cognition. CDR 0, 0.5 or 1.0. Age: 50+.
Procedures include: MRI, Amyloid, Tau, and Inflammation PET scans, LP.
(Dr. Small/Noble) Call Anna Smith 212 305-1625

Alzheimer’s Disease: EFIGA (NIH/NIA)
Genetic Study of Alzheimer’s Disease in Caribbean Hispanics
Duration: 1.5 hours visit (in person). Visits are every 2 years for the duration of the study. Hispanic individuals or families with or without memory problems willing to participate. Age: Affected any age. Unaffected 50 or older.
(Dr. Mayeux) Call Angel Piriz 212-305-2309

Alzheimer’s Disease: AD Family Based Study (FBS) (NIH/NIA)
Late and Early Onset Alzheimer’s Disease
Duration: 1.5 hours visit (in person/over the phone). Every 2 years visit for the duration of the study. Any ethnic background families with AD family history and/or with multiple affected alive members willing to participate.
Age: Affected any age. Unaffected 50 or older.
(Dr. Mayeux) Call Pamela Del Rosario 212-304-7284, email: pd2727@cumc.columbia.edu.

Alzheimer’s Disease: DAWN (NIH/NIA)
Genetic Study of Alzheimer’s Disease in Hispanics and African Americans.
Duration: 1.5 hours visit (in person/over the phone).
Hispanic or African American individuals with and without memory problems.
Age: Affected and Unaffected 60 or older
(Dr. Reitz) Call Jenny Chavez 212-342-3029 jc5835@cumc.columbia.edu
(Dr. Tosto) Call Jose Saint-Hilaire 646-317-9317 email: jls2403@cumc.columbia.edu

Alzheimer’s in African American Families (NIH/NIA)
Recruiting African American families with at least one with cognitive impairment plus another family member willing to participate.
Duration: 1.5 hours visit (in person/over the phone).
Every 2 years visit for the duration of the study.
Age: Affected any age. Unaffected 50 or older.
(Dr. Reitz ) Call Jenny Chavez 212-342-3029

Alzheimer’s Disease: Asian Cohort Alzheimer’s Disease (ACAD) (NIH/NIA)
Late Onset Alzheimer’s Disease
Duration: 2 hours visit (in person/over the phone). Every 2 years visit for the duration of the study. Chinese, Korean or Vietnamese individuals with AD family history with or without memory problems willing to participate.
Age: Affected 60 and older.
(Dr. Mayeux) Call Fangcong (Nini) Cheng: 332-257-4055

Alzheimer’s Disease: Apathy (DoD and NIA)
Study of a molecular risk factor for Apathy in AD
Duration: 2 hours visit (in person). One single visit completes study participation.
Mild to moderate AD or probable AD (MMSE≥9 and ≤26)
Males and Females, ≥50 years.
Procedures include: Fasting blood draw (~13ml), study assessments.
(Dr. Clelland) Call Ashley M. Canizares 646-774-6232

BH4 in Alzheimer’s Disease and Mild Cognitive Impairment (NIA)
Study of a Molecular Risk Factor for Cognitive Impairment in AD and MCI
Duration: 2 hours visit (in person). One single visit completes study participation. Mild to moderate or probable AD (MMSE ≥11 and ≤24, CDR=1.0); MCI (MMSE ≥24, CDR=0.5); Control (CDR=0)
Males and Females, ≥55 years.
Procedures include: Fasting blood draw (~40ml), and study assessments.
(Dr. Clelland) Call Ashley M. Canizares 646-774-6232

Frontotemporal Dementia: ALLFTD (NIH/NIA/NINDS)
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration Protocol
ClinicalTrials.gov ID NCT04363684.
Duration: 3-6 hour visits, for 1-5 years. National consortium enrolling: Behavioral Variant Frontotemporal Dementia/Non-Fluent Variant Primary Progressive Aphasia/Semantic Variant Primary Progressive Aphasia/ Frontotemporal Dementia-Amyotrophic Lateral Sclerosis.
Also enrolling asymptomatic members of families with mutation in MAPT, GRN, C9orf72, or strong family history of FTLD.
Age: ≥18, CDR 0, 0.5, 1, or 2.
Procedures include: MRI, optional LP, optional genetic testing.
(Dr. Honig) Call Andrea Farah 212 305-2371

Programs Currently Recruiting (April 2025)

GUIDE (Guiding an Improved Dementia Experience) Model Program
A Medicare-funded care coordination program for patients with dementia and their caregivers
The GUIDE model is a comprehensive, coordinated dementia care and aims to improve quality of life for people with dementia, reduce strain on their unpaid caregivers, and enable people with dementia to remain in their homes and communities. The GUIDE Model will also enhance access to the support and resources that caregivers need, including education, training and respite services.
Eligibility: must have a dementia diagnosis and CDR: 1 or greater; must have Original Medicare Part A and Part B (no Medicare Advantage plans, Special Needs Plans, or PACE programs); reside in any zip code in Manhattan, or certain parts of the Bronx (following zip codes:10451, 10452,10453, 10454,10455, 10456,10457,10458,10459,10460,10462,10463,10468,10470,10471,10472,10473,10474), has not elected the Medicare hospice benefit; and is not a long-term nursing home resident.
Contact social worker Julie Tellez, LMSW | GUIDE Patient Care Navigator email: jat2239@cumc.columbia.edu 212-305-2387

Arts and Minds
The Studio Museum in Harlem, New York Historical Society, and El Museo del Barrio
Excluded: persons with depression (only), cognitively normal persons, and patients with dementia. Spanish-speakers are welcome.
Participants will explore the world of art and culture in these interactive 75-minute programs.
(Dr. Noble) Call Carolyn Halpin-Healy 646-755-3726

A Friend for Rachel
A companionship program
MCI, early AD, early PPA, FTD (if not too behavioral), early DLB (if no hallucinations). Must be mobile and able to go out without an aide.
Participants will spend a few hours a week with their student friend either exploring NYC or staying near home.
Contact Jill Goldman email: jg2673@cumc.columbia.edu