← Trials/Trial dossier/NCT03919162

VIVA-MIND

TerminatedPhase 2Results posted

A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD

A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND)

Lead sponsor

Vivoryon Therapeutics N.V.

Asset

PQ912

Listed sites

Recruiting sites

Enrollment

112

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global ≥0.5•MMSE 20-30•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Phase 2A•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG061146-01

NCT IDNCT03919162

Org study IDPBD-01187

Timeline

Milestones

Study first posted2019-04-18actual

Study start2021-11-15actual

Primary completion2024-07-12actual

Study completion2024-08-12actual

Last update posted2025-12-12actual

Results first posted2025-12-12actual

Assets

Drug assets

PQ912

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•Age 50-89 (inclusive) at screening

•Diagnosed as having Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or Mild probable AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)

•Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening

•Montreal Cognitive Assessment score (MoCA) < 26 at screening

•Clinical Dementia Rating global score 0.5 or 1 with memory score of > 0.5 at screening

•Positive cerebrospinal fluid (CSF) AD biomarker signature

•A brain MRI scan within 6 months of screening consistent with a diagnosis of Alzheimer's disease

•Participants must have a study partner who has frequent interaction with them (approximately >3-4 times per week), will be present for all clinic visits, and can assist in compliance with study procedures

Exclusion criteria

•Significant neurodegenerative diseases and causes of dementia, other than AD, including Parkinson's disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus)

•Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic Guidelines of the NIA-AA

•Hepatic impairment defined as Child-Pugh class A or more severe liver impairment

•History of moderate or severe skin reactions to medications or current moderate or severe disease of the skin and subcutaneous tissues

•History of a major depressive episode within the past 6 months of screening

•History of diagnosis of schizophrenia

•History of uncontrolled bipolar disorder within past five years of screening

•History of seizures within past two years of screening

•Contraindication to lumbar puncture and MRI

•Monoclonal antibody treatment with anti-amyloid or anti-tau agents intended to address the pathophysiologic processes associated with AD within the previous 180 days prior to baseline (BL)

•Participants who are planning to receive treatment with aducanumab or any Amyloid Beta Antibody during the course of the study

•Participation in another clinical trial for an investigational agent and having taken at least one dose of study drug, unless confirmed as having been on placebo, within 90 days prior to the baseline visit. The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.

Endpoints (36)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Behavior / neuropsychiatric

Fluid / digital biomarkers

Other (unclassified)

Function / daily living

Global cognition

10 endpoints

Primary/protocol endpoint

Phase 2A: Change From Baseline in Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite (ABC) Score

Time frame:24 weeks

change from baseline, improvement

Primary/protocol endpoint

Phase 2B: Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:72 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Phase 2A: Change From Baseline in Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite (ABC) Score

Time frame:24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Z-scores	Standard error
PQ912n=49 Participants	-0.156	0.036
Placebon=53 Participants	-0.214	0.039

Difference LS Mean0.05895% CI-0.036 - 0.152p0.2261Mixed Models Analysis

Primary/registry result

Phase 2B: Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:72 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Box scores (0-18)	Standard error
PQ912n=17 Participants	1.63	0.36
Placebon=22 Participants	1.68	0.34

Difference LS Mean-0.0595% CI-1.03 - 0.92p0.9135Mixed Models Analysis

Secondary/protocol endpoint

Phase 2B: Key Secondary Efficacy: Change From Baseline in Cognitive Functional Composite-2 (CFC2) Score, a Cognitive Functional Composite

Time frame:72 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Phase 2B: Change From Baseline in Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite (ABC, 9-item) Score

Time frame:72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Phase 2B: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)

Time frame:72 weeks

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Phase 2B: Key Secondary Efficacy: Change From Baseline in Cognitive Functional Composite-2 (CFC2) Score, a Cognitive Functional Composite

Time frame:72 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Total score (-67 to 0)	Standard error
PQ912n=16 Participants	-6.694	1.613
Placebon=20 Participants	-7.664	1.512

Difference LS Mean0.96995% CI-3.345 - 5.238p0.6528Mixed Models Analysis

Secondary/registry result

Phase 2B: Change From Baseline in Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite (ABC, 9-item) Score

Time frame:72 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Z-scores	Standard error
PQ912n=15 Participants	-0.278	0.078
Placebon=21 Participants	-0.378	0.069

Difference LS Mean0.10095% CI-0.103 - 0.303p0.3241Mixed Models Analysis

Secondary/registry result

Phase 2B: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)

Time frame:72 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Total score (0-85)	Standard error
PQ912n=14 Participants	6.377	1.627
Placebon=19 Participants	4.343	1.470

Difference LS Mean2.03495% CI-2.292 - 6.360p0.3496Mixed Models Analysis

Function / daily living

2 endpoints

Secondary/protocol endpoint

Phase 2B: Change From Baseline in Functional Activities Questionnaire (FAQ)

Time frame:72 weeks

change from baseline, improvement

Secondary/registry result

Phase 2B: Change From Baseline in Functional Activities Questionnaire (FAQ)

Time frame:72 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Total score (0-30)	Standard error
PQ912n=17 Participants	4.36	1.35
Placebon=22 Participants	4.97	1.23

Difference LS Mean-0.6095% CI-4.22 - 3.01p0.7377Mixed Models Analysis

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Phase 2B: Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:72 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Suicidality on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to 72 weeks

event count, event

Secondary/registry result

Phase 2B: Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:72 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Total score (0-144)	Standard error
PQ912n=17 Participants	-0.14	1.80
Placebon=23 Participants	2.95	1.60

Difference LS Mean-3.0995% CI-7.81 - 1.62p0.1933Mixed Models Analysis

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Suicidality on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to 72 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912Screening - Any suicidality · Presentn=53 Participants	3	-
Screening - Any suicidality · Not presentn=53 Participants	50	-
Screening - Any suicidal ideation · Presentn=53 Participants	3	-
Screening - Any suicidal ideation · Not presentn=53 Participants	50	-
Screening - Any suicidal behavior · Presentn=53 Participants	1	-
Screening - Any suicidal behavior · Not presentn=53 Participants	52	-
Screening - Any self-injurious behavior · Presentn=53 Participants	0	-
Screening - Any self-injurious behavior · Not presentn=53 Participants	53	-
Baseline - Any suicidality · Presentn=53 Participants	4	-
Baseline - Any suicidality · Not presentn=53 Participants	49	-
Baseline - Any suicidal ideation · Presentn=53 Participants	4	-
Baseline - Any suicidal ideation · Not presentn=53 Participants	49	-
Baseline - Any suicidal behavior · Presentn=53 Participants	0	-
Baseline - Any suicidal behavior · Not presentn=53 Participants	53	-
Baseline - Any self-injurious behavior · Presentn=53 Participants	0	-
Baseline - Any self-injurious behavior · Not presentn=53 Participants	53	-
Week 4 - Any suicidality · Presentn=51 Participants	2	-
Week 4 - Any suicidality · Not presentn=51 Participants	49	-
Week 4 - Any suicidal ideation · Presentn=51 Participants	2	-
Week 4 - Any suicidal ideation · Not presentn=51 Participants	49	-
Week 4 - Any suicidal behavior · Presentn=51 Participants	0	-
Week 4 - Any suicidal behavior · Not presentn=51 Participants	51	-
Week 4 - Any self-injurious behavior · Presentn=51 Participants	0	-
Week 4 - Any self-injurious behavior · Not presentn=51 Participants	51	-
Week 8 - Any suicidality · Presentn=52 Participants	1	-
Week 8 - Any suicidality · Not presentn=52 Participants	51	-
Week 8 - Any suicidal ideation · Presentn=52 Participants	1	-
Week 8 - Any suicidal ideation · Not presentn=52 Participants	51	-
Week 8 - Any suicidal behavior · Presentn=52 Participants	0	-
Week 8 - Any suicidal behavior · Not presentn=52 Participants	52	-
Week 8 - Any self-injurious behavior · Presentn=52 Participants	0	-
Week 8 - Any self-injurious behavior · Not presentn=52 Participants	52	-
Week 12 - Any suicidality · Presentn=47 Participants	1	-
Week 12 - Any suicidality · Not presentn=47 Participants	46	-
Week 12 - Any suicidal ideation · Presentn=47 Participants	1	-
Week 12 - Any suicidal ideation · Not presentn=47 Participants	46	-
Week 12 - Any suicidal behavior · Presentn=47 Participants	0	-
Week 12 - Any suicidal behavior · Not presentn=47 Participants	47	-
Week 12 - Any self-injurious behavior · Presentn=47 Participants	0	-
Week 12 - Any self-injurious behavior · Not presentn=47 Participants	47	-
Week 16 - Any suicidality · Presentn=46 Participants	0	-
Week 16 - Any suicidality · Not presentn=46 Participants	46	-
Week 16 - Any suicidal ideation · Presentn=46 Participants	0	-
Week 16 - Any suicidal ideation · Not presentn=46 Participants	46	-
Week 16 - Any suicidal behavior · Presentn=46 Participants	0	-
Week 16 - Any suicidal behavior · Not presentn=46 Participants	46	-
Week 16 - Any self-injurious behavior · Presentn=46 Participants	0	-
Week 16 - Any self-injurious behavior · Not presentn=46 Participants	46	-
Week 24 - Any suicidality · Presentn=42 Participants	0	-
Week 24 - Any suicidality · Not presentn=42 Participants	42	-
Week 24 - Any suicidal ideation · Presentn=42 Participants	0	-
Week 24 - Any suicidal ideation · Not presentn=42 Participants	42	-
Week 24 - Any suicidal behavior · Presentn=42 Participants	0	-
Week 24 - Any suicidal behavior · Not presentn=42 Participants	42	-
Week 24 - Any self-injurious behavior · Presentn=42 Participants	0	-
Week 24 - Any self-injurious behavior · Not presentn=42 Participants	42	-
Week 36 - Any suicidality · Presentn=35 Participants	0	-
Week 36 - Any suicidality · Not presentn=35 Participants	35	-
Week 36 - Any suicidal ideation · Presentn=35 Participants	0	-
Week 36 - Any suicidal ideation · Not presentn=35 Participants	35	-
Week 36 - Any suicidal behavior · Presentn=35 Participants	0	-
Week 36 - Any suicidal behavior · Not presentn=35 Participants	35	-
Week 36 - Any self-injurious behavior · Presentn=35 Participants	0	-
Week 36 - Any self-injurious behavior · Not presentn=35 Participants	35	-
Week 48 - Any suicidality · Presentn=33 Participants	0	-
Week 48 - Any suicidality · Not presentn=33 Participants	33	-
Week 48 - Any suicidal ideation · Presentn=33 Participants	0	-
Week 48 - Any suicidal ideation · Not presentn=33 Participants	33	-
Week 48 - Any suicidal behavior · Presentn=33 Participants	0	-
Week 48 - Any suicidal behavior · Not presentn=33 Participants	33	-
Week 48 - Any self-injurious behavior · Presentn=33 Participants	0	-
Week 48 - Any self-injurious behavior · Not presentn=33 Participants	33	-
Week 60 - Any suicidality · Presentn=23 Participants	0	-
Week 60 - Any suicidality · Not presentn=23 Participants	23	-
Week 60 - Any suicidal ideation · Presentn=23 Participants	0	-
Week 60 - Any suicidal ideation · Not presentn=23 Participants	23	-
Week 60 - Any suicidal behavior · Presentn=23 Participants	0	-
Week 60 - Any suicidal behavior · Not presentn=23 Participants	23	-
Week 60 - Any self-injurious behavior · Presentn=23 Participants	0	-
Week 60 - Any self-injurious behavior · Not presentn=23 Participants	23	-
Week 72 - Any suicidality · Presentn=16 Participants	0	-
Week 72 - Any suicidality · Not presentn=16 Participants	16	-
Week 72 - Any suicidal ideation · Presentn=16 Participants	0	-
Week 72 - Any suicidal ideation · Not presentn=16 Participants	16	-
Week 72 - Any suicidal behavior · Presentn=16 Participants	0	-
Week 72 - Any suicidal behavior · Not presentn=16 Participants	16	-
Week 72 - Any self-injurious behavior · Presentn=16 Participants	0	-
Week 72 - Any self-injurious behavior · Not presentn=16 Participants	16	-
PlaceboScreening - Any suicidality · Presentn=56 Participants	4	-
Screening - Any suicidality · Not presentn=56 Participants	52	-
Screening - Any suicidal ideation · Presentn=56 Participants	4	-
Screening - Any suicidal ideation · Not presentn=56 Participants	52	-
Screening - Any suicidal behavior · Presentn=56 Participants	1	-
Screening - Any suicidal behavior · Not presentn=56 Participants	55	-
Screening - Any self-injurious behavior · Presentn=56 Participants	1	-
Screening - Any self-injurious behavior · Not presentn=56 Participants	55	-
Baseline - Any suicidality · Presentn=56 Participants	0	-
Baseline - Any suicidality · Not presentn=56 Participants	56	-
Baseline - Any suicidal ideation · Presentn=56 Participants	0	-
Baseline - Any suicidal ideation · Not presentn=56 Participants	56	-
Baseline - Any suicidal behavior · Presentn=56 Participants	0	-
Baseline - Any suicidal behavior · Not presentn=56 Participants	56	-
Baseline - Any self-injurious behavior · Presentn=56 Participants	0	-
Baseline - Any self-injurious behavior · Not presentn=56 Participants	56	-
Week 4 - Any suicidality · Presentn=55 Participants	1	-
Week 4 - Any suicidality · Not presentn=55 Participants	54	-
Week 4 - Any suicidal ideation · Presentn=55 Participants	1	-
Week 4 - Any suicidal ideation · Not presentn=55 Participants	54	-
Week 4 - Any suicidal behavior · Presentn=55 Participants	0	-
Week 4 - Any suicidal behavior · Not presentn=55 Participants	55	-
Week 4 - Any self-injurious behavior · Presentn=55 Participants	0	-
Week 4 - Any self-injurious behavior · Not presentn=55 Participants	55	-
Week 8 - Any suicidality · Presentn=50 Participants	0	-
Week 8 - Any suicidality · Not presentn=50 Participants	50	-
Week 8 - Any suicidal ideation · Presentn=50 Participants	0	-
Week 8 - Any suicidal ideation · Not presentn=50 Participants	50	-
Week 8 - Any suicidal behavior · Presentn=50 Participants	0	-
Week 8 - Any suicidal behavior · Not presentn=50 Participants	50	-
Week 8 - Any self-injurious behavior · Presentn=50 Participants	0	-
Week 8 - Any self-injurious behavior · Not presentn=50 Participants	50	-
Week 12 - Any suicidality · Presentn=47 Participants	0	-
Week 12 - Any suicidality · Not presentn=47 Participants	47	-
Week 12 - Any suicidal ideation · Presentn=47 Participants	0	-
Week 12 - Any suicidal ideation · Not presentn=47 Participants	47	-
Week 12 - Any suicidal behavior · Presentn=47 Participants	0	-
Week 12 - Any suicidal behavior · Not presentn=47 Participants	47	-
Week 12 - Any self-injurious behavior · Presentn=47 Participants	0	-
Week 12 - Any self-injurious behavior · Not presentn=47 Participants	47	-
Week 16 - Any suicidality · Presentn=45 Participants	1	-
Week 16 - Any suicidality · Not presentn=45 Participants	44	-
Week 16 - Any suicidal ideation · Presentn=45 Participants	1	-
Week 16 - Any suicidal ideation · Not presentn=45 Participants	44	-
Week 16 - Any suicidal behavior · Presentn=45 Participants	0	-
Week 16 - Any suicidal behavior · Not presentn=45 Participants	45	-
Week 16 - Any self-injurious behavior · Presentn=45 Participants	0	-
Week 16 - Any self-injurious behavior · Not presentn=45 Participants	45	-
Week 24 - Any suicidality · Presentn=44 Participants	2	-
Week 24 - Any suicidality · Not presentn=44 Participants	42	-
Week 24 - Any suicidal ideation · Presentn=44 Participants	2	-
Week 24 - Any suicidal ideation · Not presentn=44 Participants	42	-
Week 24 - Any suicidal behavior · Presentn=44 Participants	0	-
Week 24 - Any suicidal behavior · Not presentn=44 Participants	44	-
Week 24 - Any self-injurious behavior · Presentn=44 Participants	0	-
Week 24 - Any self-injurious behavior · Not presentn=44 Participants	44	-
Week 36 - Any suicidality · Presentn=37 Participants	1	-
Week 36 - Any suicidality · Not presentn=37 Participants	36	-
Week 36 - Any suicidal ideation · Presentn=37 Participants	1	-
Week 36 - Any suicidal ideation · Not presentn=37 Participants	36	-
Week 36 - Any suicidal behavior · Presentn=37 Participants	0	-
Week 36 - Any suicidal behavior · Not presentn=37 Participants	37	-
Week 36 - Any self-injurious behavior · Presentn=37 Participants	0	-
Week 36 - Any self-injurious behavior · Not presentn=37 Participants	37	-
Week 48 - Any suicidality · Presentn=33 Participants	0	-
Week 48 - Any suicidality · Not presentn=33 Participants	33	-
Week 48 - Any suicidal ideation · Presentn=33 Participants	0	-
Week 48 - Any suicidal ideation · Not presentn=33 Participants	33	-
Week 48 - Any suicidal behavior · Presentn=33 Participants	0	-
Week 48 - Any suicidal behavior · Not presentn=33 Participants	33	-
Week 48 - Any self-injurious behavior · Presentn=33 Participants	0	-
Week 48 - Any self-injurious behavior · Not presentn=33 Participants	33	-
Week 60 - Any suicidality · Presentn=28 Participants	1	-
Week 60 - Any suicidality · Not presentn=28 Participants	27	-
Week 60 - Any suicidal ideation · Presentn=28 Participants	1	-
Week 60 - Any suicidal ideation · Not presentn=28 Participants	27	-
Week 60 - Any suicidal behavior · Presentn=28 Participants	0	-
Week 60 - Any suicidal behavior · Not presentn=28 Participants	28	-
Week 60 - Any self-injurious behavior · Presentn=28 Participants	0	-
Week 60 - Any self-injurious behavior · Not presentn=28 Participants	28	-
Week 72 - Any suicidality · Presentn=20 Participants	0	-
Week 72 - Any suicidality · Not presentn=20 Participants	20	-
Week 72 - Any suicidal ideation · Presentn=20 Participants	0	-
Week 72 - Any suicidal ideation · Not presentn=20 Participants	20	-
Week 72 - Any suicidal behavior · Presentn=20 Participants	0	-
Week 72 - Any suicidal behavior · Not presentn=20 Participants	20	-
Week 72 - Any self-injurious behavior · Presentn=20 Participants	0	-
Week 72 - Any self-injurious behavior · Not presentn=20 Participants	20	-

Fluid / digital biomarkers

4 endpoints

Primary/protocol endpoint

Phase 2A: Median Estimated Target Occupancy (TO) of PQ912 in Cerebrospinal Fluid (CSF) at Week 24

Time frame:Week 24, pre-dose (trough level) and 2-3h post-dose

concentration, descriptive

Primary/protocol endpoint

Phase 2A: Median Plasma Concentrations of PQ912 at Week 24

Time frame:Week 24, pre-dose (trough level) and 2-3h post-dose

concentration, descriptive

Primary/registry result

Phase 2A: Median Estimated Target Occupancy (TO) of PQ912 in Cerebrospinal Fluid (CSF) at Week 24

Time frame:Week 24, pre-dose (trough level) and 2-3h post-dose

concentration, descriptive

Posted result

Group	Value (median), Percent (%)	Reported bounds
PQ912Week 24 (Visit 7) - pre-dosen=37 Participants	55.3	-0.0 - 86.4
Week 24 (Visit 7) - 2-3h post-dosen=24 Participants	94.3	-31.6 - 97.7

Primary/registry result

Phase 2A: Median Plasma Concentrations of PQ912 at Week 24

Time frame:Week 24, pre-dose (trough level) and 2-3h post-dose

concentration, descriptive

Posted result

Group	Value (median), ng/mL	Reported bounds
PQ912Week 24 (Visit 7) - pre-dosen=37 Participants	208.0	-0.0 - 1070.0
Week 24 (Visit 7) - 2-3h post-dosen=24 Participants	2790.0	-77.7 - 7210.0

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Phase 2A: Number of Participants With Any Adverse Event of Special Interest (AESI)

Time frame:From first dose to completion of 8 weeks on the full dose (Week 16)

threshold achievement, event

Primary/registry result

Phase 2A: Number of Participants With Any Adverse Event of Special Interest (AESI)

Time frame:From first dose to completion of 8 weeks on the full dose (Week 16)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=27 Participants	1	-
Placebon=33 Participants	2	-

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Treatment-emergent Serious Adverse Events (SAEs)

Time frame:76 weeks

event count, event

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Mortality Rates

Time frame:76 weeks

event count, event

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Treatment-emergent Adverse Events (TEAEs)

Time frame:76 weeks

event count, event

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Adverse Events of Special Interest (AESIs)

Time frame:76 weeks

event count, event

Secondary/protocol endpoint

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Drug Discontinuation Rates

Time frame:72 weeks

event count, event

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Treatment-emergent Serious Adverse Events (SAEs)

Time frame:76 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=53 Participants	11	-
Placebon=56 Participants	6	-

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Mortality Rates

Time frame:76 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=53 Participants	2	-
Placebon=56 Participants	0	-

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Treatment-emergent Adverse Events (TEAEs)

Time frame:76 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=53 Participants	46	-
Placebon=56 Participants	47	-

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Rates of All Adverse Events of Special Interest (AESIs)

Time frame:76 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=53 Participants	1	-
Placebon=56 Participants	3	-

Secondary/registry result

Phase 2B: Assessment of the Longer-term Safety and Tolerability of PQ912 as Measured by Drug Discontinuation Rates

Time frame:72 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PQ912n=53 Participants	6	-
Placebon=56 Participants	2	-

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Phase 2A: Change From Baseline in Quantitative Electroencephalogram (qEEG)

Time frame:24 weeks

change from baseline, improvement

Primary/registry result/low confidence

Phase 2A: Change From Baseline in Quantitative Electroencephalogram (qEEG)

Time frame:24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Proportion (0-1)	Standard error
PQ912n=24 Participants	0.01749	0.00649
Placebon=25 Participants	0.02275	0.00619

Difference LS Mean-0.0052695% CI-0.02017 - 0.00964p0.4814Mixed Models Analysis

Secondary/protocol endpoint/low confidence

Phase 2B: Change From Baseline in Quantitative Electroencephalogram (qEEG)

Time frame:72 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Phase 2B: Change From Baseline in Quantitative Electroencephalogram (qEEG)

Time frame:72 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Proportion (0-1)	Standard error
PQ912n=8 Participants	-0.01123	0.01474
Placebon=10 Participants	0.01734	0.01291

Difference LS Mean-0.0285795% CI-0.06746 - 0.01032p0.1398Mixed Models Analysis

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.