Alzheimer DiseasePhase 2NCT06847321
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
A Phase 2 study testing LHP588 in people with Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis, run by Lighthouse Pharmaceuticals, Inc. at 39 sites in United States.
Trial summary
This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease Due to P. Gingivalis
- What is being tested?
- LHP588
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 39 sitesUnited States
- Study dates
- 17 Feb 2025to 15 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AD according to the National Institute on Aging-Alzheimer's Association criteria.
- MMSE scores corresponding to mild and moderate AD.
- Saliva rinse sample positive for P. gingivalis.
- Plasma pTau217 above cutoff.
- Subject and caregiver have provided full written informed consent.
- Background symptomatic therapy with acetylcholinesterase inhibitors, and/or memantine, are allowed if the dose has been stable for 90 days and no changes are planned during the study.
- Modified Hachinski score ≤4 at screening.
Who cannot join
- History of cancer requiring systemic therapy in last 5 years.
- Evidence of a clinically significant, unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within 6 months prior to screening.
- Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.
- Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic at screening visit.
- History or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's Disease, other.
- Currently being treated with anti-amyloid beta antibodies or other disease-modifying treatments for dementia.
- Other criteria in the Investigator's judgement that may interfere with the ability to participate in the study.
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
United States39 sites, 37 recruiting
- Recruiting
Alzheimer's Disease Research Center
Albany, New York, 12208
Richard Holub, MD, 518-426-0575, research@naaresearch.com
Richard Holub, MD
- Recruiting
IMA Evaluations
Albuquerque, New Mexico, 87109
Valerie Ramirez, 505-848-3773, valerie.ramirez@imaresearch.com
Daniel Collins, MD
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
Linda Pao, MD, 561-968-2933, jem.research@jemri.net
Linda Pao, MD
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
Study Coordinator, 425-453-0404, study.coordinator@nwcrc.net
study.coordinator@nwcrc.net
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
Megan Norris, 617-362-4386, mnorris@adamsclinical.com
Darin Dougherty, MD
- Recruiting
University of Virginia Adult Neurology
Charlottesville, Virginia, 22903
Colleen Webber, 434-243-5898, cmn6x@virginia.edu
Carol Manning, PhD
- Recruiting
Clinical Research Professionals - Headlands
Chesterfield, Missouri, 63005
Recruitment, 636-220-1200, recruitment@clinicalresearchprofessionals.net
Siddarth Kaul, MD, PhD
- Recruiting
Columbus Memory Center
Columbus, Georgia, 31909
Mark Stafford, 706-653-8455, info@researchalz.com
Mark Stafford, DO
- Recruiting
Kerwin Research Center, LLC - Oak Cliff
Dallas, Texas, 75216
Megha Chadha, 972-433-9100, enroll@kerwinmedical.com
Zaid Shah, DO
- Recruiting
Kerwin Research Center, LLC in Texas
Dallas, Texas, 75231
Megha Chadha, 972-433-9100, enroll@kerwinmedical.com
Alka Khera, MD
- Recruiting
NDx Clinical Research
Dayton, Ohio, 45459
Study Team, 937-224-8200 ext. 5, Contact@NdxResearch.com
Joel Vandersluis, MD
- Recruiting
Brain Matters Research
Delray Beach, Florida, 33445
Jen Blasi, 561-374-8461, jblasi@ergclinical.com
RecruitmentBMR@ergclinical.com
- Recruiting
CenExel Denver, CO
Englewood, Colorado, 80113
Susan McPhie, 720-477-7899, rmcr.recruitment@cenexel.com
Katherine Coerver, MD, PhD
- Active, not recruiting
Re-Cognition Health Fairfax
Fairfax, Virginia, 22031
- Recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Jacqueline Acosta, 239-939-7777, recruitmentnprc@ergclinical.com
Jennifer Springer, MD
- Recruiting
Center for Advanced Research & Education Flourish-Gainesville
Gainsville, Georgia, 30501
Tina Foreman, 770-534-5154, tforeman@flourishresearch.com
Angela Ritter, MD
- Recruiting
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Krista-Elizabeth Hanley, 601-579-5016, bree.hanley@hattiesburgclinic.com
Ronald Schwartz, MD
- Recruiting
Tandem Clinical Research - Metairie
Metairie, Louisiana, 70006
Tandem Clinical Research - Recruitment, 504-321-1700, recruitment@tandemclinicalresearch.com
Angela Traylor, MD
- Recruiting
Esperanza Clinical
Murrieta, California, 92562
Antonio Mason-Villeda, 951-417-4466, hello@esperanzaclinical.com
Michael Ropacki, PhD
- Recruiting
K2 Medical Research Nashville LLC
Nashville, Tennessee, 37204
Victoria Marsh, 615-208-5252, victoria.marsh@k2med.com
Joshua Lennon, MD
- Recruiting
Adams Clinic Harlem
New York, New York, 10029
Outreach Recruitment Team, 646-917-6804, jmoraleslu@adamsclinical.com
Rachel Noone, MD
- Recruiting
Oakland Clinical Research
Oakland, California, 94609
Crystal Huynh, 510-817-2000, crystal@irvineclinical.com
Richard Parenteau, MD
- Recruiting
ATP Clinical Research, Inc.
Orange, California, 92866
Christine Som, 714-662-9556, christines@pnsoc.com
Bobby Shih, 714-453-4114, bshih@atpcr.com
- Recruiting
Conquest Research - Lake Nona
Orlando, Florida, 32832
Daniela LaraRivillas, 407-916-0060, Daniela.LaraRivillas@conquestresearch.com
Gilbert Mbeo, MD
- Active, not recruiting
Anchor Neuroscience
Pensacola, Florida, 32502
- Recruiting
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Laura Martinez, SCRC, 602-839-6500, BannerAlzResearch@bannerhealth.com
Allison Perrin, MD
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Margeaux Snell, MD, CCRC, 602-406-3378, Margeaux.snell@commonspirit.org
Anna Burke, MD
- Recruiting
Headlands PharmaSite
Pikesville, Maryland, 21208
Aparna Ayyala, 410-699-9833, aparna.ayyala@pharmasiteresearch.com
Sarah Herts, DO
- Recruiting
Headlands Research-EMA
Plymouth, Massachusetts, 02360
Jay Patel, 508-746-5060 ext. 103, jay.patel@headlandsresearchema.com
Kinan Hreib, MD, PhD
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Kyrie Allen, 386-304-7070, kyriem@progressivemedicalresearch.com
Alex White, MD
- Recruiting
Summitt Research
Portland, Oregon, 97210
Annika Truitt, 503-972-9822, annika.truitt@summittnetwork.com
Scott Losk, PhD
- Recruiting
Riverside Clinical Research
Riverside, California, 92506
Erick Delgado, 951-374-8000, edelgado@irvineclinical.com
Cydney Osano, MD
- Recruiting
Clinical Endpoints
Scottsdale, Arizona, 85258
Jenna Leger, 480-566-9090, jleger@clinicalendpoints.com
Allan Block, MD
- Recruiting
CenExel Sherman Oaks
Sherman Oaks, California, 91403
Mekaela Theobald, (818) 990-2671, m.theobald@cenexel.com
Thomas Shiovitz, MD
- Recruiting
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, 34997
Adam Falchook, MD, 772-675-0000, info@researchalz.com
Adam Falchook, MD
- Recruiting
CenExel Research - Toms River
Toms River, New Jersey, 08755
Anna Brocco, 732-341-9500 ext. 3510, amri.recruitment@cenexel.com
Arun Singh, MD
- Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, 02472
Nova Chenda, 617-362-4386, Nchenda@adamsclinical.com
Stephanie Rutrick, MD
- Recruiting
Alzheimer's Research and Treatment Center - Wellington
Wellington, Florida, 33414
Annet Falchook, MD, 561-209-2400, info@researchalz.com
Annet Falchook, MD
- Recruiting
Ascension via Christi Research
Wichita, Kansas, 67214
Angie Vincent, 316-268-6055, angie.vincent@ascension.org
Paul Murphy, MD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy and safety of LHP588 in participants with evidence of P. gingivalis [Pg] infection and Alzheimer's Disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) research criteria. Enrolled participants must also have evidence of P. gingivalis infection as determined by polymerase chain reaction (PCR) of saliva oral rinse and clinical evidence of progressive cognitive decline in the last year. The participant should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia based on prior imaging and the screening magnetic resonance imaging (MRI). Due to the nature of AD, participants must identify a primary caregiver prior to enrollment in the study who will assist the participant with study participation and attend clinic visits.
The study will consist of the following periods: 1) screening period of up to 12 weeks, 2) double-blind treatment period of 48 weeks (including a 2 week up-titration for the high dose arm), and 3) safety follow-up period of 4 weeks.
The screening period will include at least two office visits during which eligibility will be verified. The first screening visit assessments will be limited to include the Mini-Mental State Examination (MMSE), saliva sample collection to assess Pg positivity, and pTau217 sample collection. The second screening visit will only be scheduled for participants with positive results of Pg infection and pTau217 test, and the rest of the screening procedures will be performed. Screening MRI will be performed as the last eligibility verification assessment.
Participants who meet all eligibility criteria will be randomized in a 1:1:1 fashion to receive LHP588 25 mg, LHP588 50 mg, or placebo, orally, once daily (QD) in a fasted state (at least one hour before or two hours after a meal) for 48 weeks. Dosing should be done at approximately the same time each day. Blood samples for pharmacokinetics levels and biomarkers will be collected during selected visits.
Evaluations will be conducted according to the schedule of assessments and will include: Medical history, physical examination, height, weight, saliva rinse for verification of Pg infection, blood for pharmacokinetic analysis, safely laboratory measures, electrocardiogram, and cognitive and functional scale assessments such as ADAS Cog, administered periodically.
After completion of study treatment, participants will continue to be monitored for 4 weeks and will have a phone call to assess safety at Week 50 and will return for the Safety Follow-up Visit (Week 52).
- Being tested
- LHP588, Placebo Drug
- Keywords
- placebo-controlled, p. gingivalis, Alzheimer disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHP588Drug
Also called Low dose
25 mg, once daily
LHP588Drug
Also called High dose
50 mg, once daily
Placebo DrugDrug
Placebo, once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two (2) placebo capsules, once daily, for 48 weeks Receives: Drug: Placebo Drug |
| LHP588 25 mg | Experimental | One (1) 25 mg capsule and one (1) placebo capsule, once daily, for 48 weeks Receives: Drug: LHP588 |
| LHP588 50 mg | Experimental | Two (2) 25 mg capsules, once daily, for 48 weeks Receives: Drug: LHP588 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADAS-Cog11
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Measured: 40 - 48 weeks
Secondary outcomes (3)
Change in ADCS-ADL
ADCS-ADL is the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living
Measured: 40 - 48 weeks
Change in CMAI
CMAI is the Cohen-Mansfield Agitation Inventory
Measured: 40 - 48 weeks
Change in CDR-SB
CDR-SB is the Clinical Dementia Rating-Sum of Boxes
Measured: 40 - 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start17 Feb 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lighthouse Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Dominy, MD, Study director, Lighthouse Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847321
- Sponsor's protocol ID
- LHP588-201
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06847321
- Acronym / sponsor ID
- LHP588-201
- Keywords
- placebo-controlled, p. gingivalis, Alzheimer disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lighthouse Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.
Detailed description
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy and safety of LHP588 in participants with evidence of P. gingivalis [Pg] infection and Alzheimer's Disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) research criteria. Enrolled participants must also have evidence of P. gingivalis infection as determined by polymerase chain reaction (PCR) of saliva oral rinse and clinical evidence of progressive cognitive decline in the last year. The participant should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia based on prior imaging and the screening magnetic resonance imaging (MRI). Due to the nature of AD, participants must identify a primary caregiver prior to enrollment in the study who will assist the participant with study participation and attend clinic visits.
The study will consist of the following periods: 1) screening period of up to 12 weeks, 2) double-blind treatment period of 48 weeks (including a 2 week up-titration for the high dose arm), and 3) safety follow-up period of 4 weeks.
The screening period will include at least two office visits during which eligibility will be verified. The first screening visit assessments will be limited to include the Mini-Mental State Examination (MMSE), saliva sample collection to assess Pg positivity, and pTau217 sample collection. The second screening visit will only be scheduled for participants with positive results of Pg infection and pTau217 test, and the rest of the screening procedures will be performed. Screening MRI will be performed as the last eligibility verification assessment.
Participants who meet all eligibility criteria will be randomized in a 1:1:1 fashion to receive LHP588 25 mg, LHP588 50 mg, or placebo, orally, once daily (QD) in a fasted state (at least one hour before or two hours after a meal) for 48 weeks. Dosing should be done at approximately the same time each day. Blood samples for pharmacokinetics levels and biomarkers will be collected during selected visits.
Evaluations will be conducted according to the schedule of assessments and will include: Medical history, physical examination, height, weight, saliva rinse for verification of Pg infection, blood for pharmacokinetic analysis, safely laboratory measures, electrocardiogram, and cognitive and functional scale assessments such as ADAS Cog, administered periodically.
After completion of study treatment, participants will continue to be monitored for 4 weeks and will have a phone call to assess safety at Week 50 and will return for the Safety Follow-up Visit (Week 52).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo DrugTwo (2) placebo capsules, once daily, for 48 weeks |
| LHP588 25 mg | Experimental | Drug: LHP588One (1) 25 mg capsule and one (1) placebo capsule, once daily, for 48 weeks |
| LHP588 50 mg | Experimental | Drug: LHP588Two (2) 25 mg capsules, once daily, for 48 weeks |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AD according to the National Institute on Aging-Alzheimer's Association criteria.
- MMSE scores corresponding to mild and moderate AD.
- Saliva rinse sample positive for P. gingivalis.
- Plasma pTau217 above cutoff.
- Subject and caregiver have provided full written informed consent.
Key exclusion criteria (7 listed)
- History of cancer requiring systemic therapy in last 5 years.
- Evidence of a clinically significant, unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within 6 months prior to screening.
- Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.
- Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic at screening visit.
- History or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's Disease, other.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHP588Also: Low dose25 mg, once daily | Drug | LHP588 25 mg |
| LHP588Also: High dose50 mg, once daily | Drug | LHP588 50 mg |
| Placebo DrugPlacebo, once daily | Drug | Placebo |
Primary outcome
Change in ADAS-Cog11
Time frame: 40 - 48 weeks
ADAS-COG11 is the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
3 secondary outcomes
Change in ADCS-ADL
Time frame: 40 - 48 weeks
Change in CMAI
Time frame: 40 - 48 weeks
Change in CDR-SB
Time frame: 40 - 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Dominy, MD study director
Lighthouse Pharmaceuticals, Inc.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LHP588 in people with Alzheimer Disease and Alzheimer Disease Due to P. Gingivalis, run by Lighthouse Pharmaceuticals, Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Bolger (858-248-5124, jbolger@lighthousepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADAS-Cog11 (time frame: 40 - 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.