ClinicalTrials.gg
Active, not recruitingNCT05531656Updated Aug 10, 2026

A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

A Phase 2 interventional study of CT1812 and Placebo in Early Alzheimer's Disease, sponsored by Cognition Therapeutics. Active, not recruiting at 50 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Cognition Therapeutics · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.

Planned enrollment
173rd of 1,608
540 · median 73
Started
2023
with 114 others
Phase 2
360 of 1,939
50 open now
Primary completion
2027-05
later than 183 of 444 live
Registered
1,485th of 1,939
by date

Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 173rd largest by planned enrollment of the 1,608 interventional ones that give a count, is one of 115 that started in 2023, is one of 360 in phase 2, reaches primary completion later than 183 of the 444 other live ones, and was the 1,485th registered.

Alzheimer Disease

3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:

340 more — sign in →

All 345 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.

This study: 50 Years to 85 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,939 studies in Alzheimer Disease with a site in United States, or all of them as a file.
02

Study summary

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

Read the detailed description

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease

Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

03

Conditions studied

  • Early Alzheimer's Disease

Browse trials for

Keywords

  • Alzheimer's Disease
04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ages 50-85 years.
  2. Diagnosis of either MCI due to AD or mild AD dementia.
  3. 20-30 (inclusive).
  4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
  5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.

Exclusion criteria

Exclusion Criteria:

  1. Screening MRI of the brain indicative of significant abnormality.
  2. abnormalities in screening laboratory tests.
  3. Clinical or laboratory findings consistent with:

    1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
    2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
    3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
  4. A participant known to be actively infected with or at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
  5. A current diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
540 participants (estimated)

Study arms

  • Active comparator
    CT1812 100 mg

    CT1812 at a dose of 100 n=180 group

    Drug: CT1812

  • Active comparator
    CT1812 200 mg

    CT1812 at a dose of 300mg, n=180 group

    Drug: CT1812

  • Placebo comparator
    Placebo

    Placebo, n=180 group

    Drug: Placebo

Interventions

  • DrugCT1812

    Study Drug

    Also known as: Study Drug Active

  • DrugPlacebo

    Non-active study drug

    Also known as: Matching Placebo

06

What researchers measure

Primary outcomes

  1. Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.

    The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.

    Time frame: 18 months

Secondary outcomes

  1. Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)

    Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.

    Time frame: 18 months

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.

    Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.

    Time frame: 18 months

  3. Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.

    Change from baseline at 18 months.

    Time frame: 18 months

  4. Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)

    Change from baseline at 18 months.

    Time frame: 18 months

  5. Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change

    Change from baseline at 18 months.

    Time frame: 18 months

07

Study locations

50 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for May 2027, 47 months after the start.

Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 47 months is above that.

Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2022
First posted
Sep 8, 2022
StartActual
Jun 28, 2023
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531656
Lead sponsor
Cognition Therapeutics
Collaborators
National Institute on Aging (NIA), Alzheimer's Clinical Trials Consortium
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Jun 28, 2023
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Anthony Caggiano, MD
study director · Cognition Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Zervimesine

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