Taub Institute: Genomics Core
AN NIA-FUNDED ALZHEIMER'S DISEASE RESEARCH CENTER

 

Columbia University
Irving Medical Center
Neurological Institute

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


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Clinical Trials

Clinical Trials Currently Recruiting (October 2022)



Alzheimer’s Disease: INVOKE-2 AL002-2 (Alector Inc)
A Phase 2 Study for Safety and Tolerability of AL002.
Phase 2. IV Infusion. Every 4 weeks. Duration: about 52-96 weeks. NCT04592874.
AD. MMSE: ≥22. Age: 50-85.
Procedures include: MRI (total: 3), LP (total: 3), Amyloid PET scan (total: 3).
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Mild Cognitive Impairment/ Alzheimer’s Disease: SIGNAL-AD Pepinemab (Vaccinex, Inc)
SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease.
Phase 1b/2a. IV Infusion. Monthly. Duration: about 40 weeks. NCT04381468.
MCI due to AD/AD. MMSE: 17-26. Age: 55-85.
Procedures include: MRI (total: 2), LP (with positive historical Amyloid PET before screening: 1; otherwise, 2).
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Mild Cognitive Impairment/ Alzheimer’s Disease: ACU193 (Acumen Pharmaceuticals)
A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants with MCI or Mild AD.
Phase 1. IV Infusion. 1 to 3 doses every 4 weeks. Duration: about 20,24, or 28 weeks. NCT04931459.
MCI/AD. MMSE: 20-30. Age: 55-90.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

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
Phase 1. Duration:5 visits. NCT04118764.
Amnestic Mild Cognitive Impairment/Alzheimer’s Disease. MMSE: 12-26. Age: ≥50.
Procedures include: MRI, head ultrasound.
(Dr. Honig/Dr. Konofagou) Call Katherine Liu 212-342-1612

UPCOMING: Healthy Volunteers/Mild Cognitive Impairment/ Alzheimer’s Disease: [18F]APN-1607 (Aprinoia)
Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects.
Phase 2. PET imaging using [18F]APN-1607. Two visits (PET only). Duration: about 1 month. NCT04141150.
Controls/MCI/AD. MMSE: ≥ 27 (Controls), 24-30 (MCI), 10-26 (AD). Age: 50-85.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Preclinical Alzheimer’s Disease: AHEAD 3-45 BAN2401 (Eisai Inc.)
A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical AD and Elevated Amyloid and Also in Participants With Early Preclinical AD and Intermediate Amyloid.
Phase 3. Intravenous infusion every 2 or 4 weeks depending on the assigned arm. Duration: about 4 years. NCT04468659.
Preclinical AD. MMSE: ≥ 27. Age: 55-80.
Procedures include: MRI (total: 13), Amyloid PET (total: 3), Tau PET (total: 3), LP (optional)
(Dr. Bell) Call Chrismary De La Cruz 212-305-7661

UPCOMING: Preclinical Alzheimer’s Disease: SKYLINE Gantenerumab (Hoffmann-La Roche)
A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease. NCT05256134.
Phase 3. Subcutaneous (SC) Injection. 1 SC every 1 week or 2 SC every 2 weeks. Duration: about 4 years.
Preclinical AD. CDR: 0. Age: 60-80.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Mild Cognitive Impairment: VALMCI valacyclovir (Alzheimer’s Association)
Anti-viral therapy in Mild Cognitive Impairment.
Phase 2. Oral Medication. Twice daily. Duration: 52 Weeks (12 months). NCT04710030.
Early and Late Mild Cognitive Impairment; positive screening tests results for antibodies to HSV1 or HSV2. MMSE: 23-30. Age: 50-95.
Procedures include: MRI (total: 2), Amyloid PET scan (total: 2).
(Dr. Devanand) Call Memory Disorders Clinic 646-774-8665

Alzheimer's Disease: S-CitAD escitalopram (NIA)
Escitalopram for Agitation in Alzheimer’s disease.
Phase 3. Psychosocial Intervention and Oral Medication. Duration: 24 Weeks (6 months). NCT03108846.
Alzheimer's disease (AD) with agitation. MMSE: 5-28. Age: 55-95.
(Dr. Devanand) Call Izael Nino 646-774-8671

UPCOMING: Dementia with Lewy Bodies: COG1201 CT1812 (NIH/NIA; Cognition Therapeutics)
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects with Mild to Moderate Dementia with Lewy Bodies.
Phase 2. Oral Medication. Once daily. Duration: about 6 months. NCT05225415.
DLB. Age: 50-85.
Procedures include: MRI, LP.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Frontotemporal Dementia: INFRONT-3 AL001-3 (Alector Inc)
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia.
Phase 3. IV Infusion every 4 weeks. Duration: about 96 weeks. NCT04374136.
FTD. Carrier of progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker or diagnosed with FTD. CDR 0, 0.5, 1, or 2. Age: 18-85.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Amyotrophic Lateral Sclerosis with or without Frontotemporal Dementia: TPN-101 (Transposon Therapeutics, Inc.)
A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD
Phase 2a. Oral Medication. Once daily. Duration: about 48 weeks. NCT04993755.
ALS with or without FTD. MMSE: ≥ 18. Age: 18 years and older.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Frontotemporal Dementia: FOXY (Lawson Health Research Institute)
A Phase 2 Clinical Trial of Oxytocin for Frontotemporal Dementia
Phase 2/3. Intranasal spray. Twice daily. Duration: 24 Weeks. NCT03260920.
FTD. MMSE: 10-30. Age: 30-80. 
(Dr. Huey) Call Masood Manoochehri 212-305-5710

Frontotemporal Dementia: lithium (ADDF)
Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia
Phase 2/3. Oral Medication. Once daily. Duration: 12 Weeks. NCT02862210.
FTD. MMSE: 5-26. Age: 40-85. 
(Dr. Huey) Call Masood Manoochehri 212-305-5710

Observational Studies Currently Recruiting (October 2022)


UPCOMING: Mild Cognitive Impairment or Dementia: New IDEAS
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study.
Mild Cognitive Impairment (MCI) or dementia. Medicare as primary insurance. NCT04426539.
Age: ≥18.
(Dr. Honig) Call Katrina Cuasay 212-305-2077

Mild Cognitive Impairment/Early Onset Alzheimer’s Disease/Normal Cognition: LEADS (NIH/NIA)
Longitudinal Early Onset Alzheimer’s Disease
Duration: 2 years, yearly visit. NCT03507257.
Mild Cognitive Impairment/Early Onset Alzheimer’s Disease/Normal Cognition. CDR 0, 0.5 or 1.0 (MCI/AD). Age: 40-64.
Procedures include: MRI, Amyloid and Tau Pet scan, optional LP.
(Dr. Honig) Call Arlene Mejia 212-305-9168

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 Arlene Mejia 212-305-9168

Mild Alzheimer's Disease/Normal Cognition: AD Autoimmune (NIH/NINDS)
Autoimmune features in neurodegenerative disorders
Duration: 1 to 2 visits. 1.5hrs per visit. NCT04239079.
Mild Alzheimer's Disease/Amnestic Mild Cognitive Impairment/Normal Cognition. AD: MMSE: 20-26, CDR 0.5-1. Age: ≥55.
Procedures include: 100ml blood draw.
(Dr. Marder) Call Kim Tran 646-774-5023

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
Duration: 2 years, baseline visits and 2 year follow up. NCT04576793.
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: 50-70.
Procedures include: MRI, Amyloid, Tau, and Inflammation PET scans, LP.
(Dr. Small/Noble) Call Galen Ziaggi 212-305-9194

Mild Cognitive Impairment/Alzheimer's Disease: PAM (NIH/NIA)
Discovery and validation of genetic variants affecting microglial activation in Alzheimer's disease
Duration: 5 years, baseline MRI/PET scan and 4 year follow up for blood draw/cognitive testing.
aMCI/AD/Normal Cognition (with prior LP or amyloid PET scan). CDR 0, 0.5 or 1.0. Age: ≥ 50.
Procedures include: MRI, Inflammation PET scan. 
(Dr. De Jager/Dr. Kreisl) Call Galen Ziaggi 212-305-9194

Alzheimer’s Disease: DIAN (NIH/NIA)
Dominantly Inherited Alzheimer Network
Duration: Years. Every 1 to 3 years visits. NCT00869817.
Family members of a person with AD (proband) due to PSEN1, PSEN2, or APP mutations. MMSE: any. Age: ≥18; younger but no more than 10 years younger than proband’s AAO.
(Dr. Noble) Call Arlene Mejia 212-305-9168

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 families with multiple affected alive-siblings (2+) and an additional individual healthy or not, willing to participate.
Age: Affected any age. Unaffected 50 or older.
(Dr. Mayeux) Call Angel Piriz 212-305-2309

Alzheimer’s Disease: LOAD (NIH/NIA)
Late 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 multiple affected alive-siblings (2+) and an additional individual healthy or not, willing to participate;
Age: Affected any age. Unaffected 50 or older.
(Dr. Mayeux) Call Dolly Reyes-Dumeyer 212-305-5953, Izri Martinez (For African American participants) 212-305-2349

Alzheimer’s Disease: READR (NIH/NIA)
Resource for Early Onset Alzheimer’s Disease Research: Early Onset Alzheimer’s Disease Whole Genome Sequencing
The goal is to identify unknown mutations (other than APP, PSEN1 and PSEN2) Duration: 1.5 hours visit (in person/over the phone). Every 2 years visit for the duration of the study.
Age: Onset of memory problems before the age of 65.
(Dr. Reitz) Call Penelope Baez 201-640-4335

Subjective Cognitive Complaint: SCD Project (NIH/NIA)
Characterizing Subjective Cognitive Decline in Older Adults
Duration: 1 visit. 1.5hrs.
Subjective Cognitive Complaint. Age: ≥56.
Procedures include: cognitive testing.
(Dr. Cosentino) Call Jillian Joyce 212-342-1969

Dementia with Lewy Bodies: Targeting Lewy Body Pathology (NIH/NINDS)
Targeting Lewy Body Specific Pathology Using Biomarkers
Duration: 3-5 years.
Mild Cognitive Impairment due to Dementia with Lewy Bodies/Dementia with Lewy Bodies/Parkinson’s Disease Dementia.
Procedures include: optional LP.
(Dr. Marder/Dr. Honig) Call Helen Mejia-Santana 212- 305-9183

Neurodegenerative diseases/Mild Cognitive Impairment/Normal Cognition: NAPS (NIH)
Neurodegeneration-Associated Psychiatric Symptoms
Duration: 1 visit, 4-5 hours.
Alzheimer's disease, Frontotemporal dementia, Primary Progressive Aphasia, Dementia with Lewy Bodies, Parkinson’s disease, Huntington's disease, Mild Cognitive Impairment, Healthy Controls. Age: 40-90.
Procedures include: MRI.
(Dr. Huey) Call Yedili Genao-Perez 212-305-3187

Tauopathies/Progressive Supranuclear Palsy / Corticobasal Syndrome: 4RTNI2 (NIH/NIA)
4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2
Duration: 1-3 day visits every 6 months, for 1-2 years. NCT02966145
PSP/ variant PSP syndrome/Non-fluent Variant PPA/Corticobasal Syndrome. Age: 40-80, CDR 0, 0.5, or 1.
Procedures include: MRI, tau and amyloid PET scan, optional LP.
(Dr. Huey) Call Masood Manoochehri 212-305-5710

Frontotemporal Dementia: ALLFTD (NIH/NIA/NINDS)
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration Protocol
Duration: 3-6 hour visits, for 1-5 years. NCT04363684
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. Huey) Call Masood Manoochehri 212-305-5710

Programs Currently Recruiting (October 2022)


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.
Call Jill Goldman 212-305-7382

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