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PQ912 for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alzheimer's Disease+2 MorePQ912 - Drug
Eligibility
50 - 89
All Sexes
What conditions do you have?
Select

Study Summary

This trial will have two parts. In the first part, 180 people will take either a placebo or one of three different doses of the drug being studied. This will go on for at least 24 weeks. The second part, which will only happen if the first part shows promise, will involve 414 people taking the drug or a placebo for a longer period of time to see if it improves cognitive function and has other benefits.

Eligible Conditions
  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 1 Secondary · Reporting Duration: 72 weeks

24 weeks
2A Primary PK: derived mean values of varoglutamstat levels and corresponding calculated target occupancy (TO)
2A Primary efficacy: The within-participant change from baseline to week 24 in the composite sum of standardized scores from the ADNI Battery Composite (ABC, 9-item) compared between active arm and placebo.
2A Primary efficacy:The within-participant change from baseline to week 24 in quantitative EEG (global relative theta wave power)
2A Primary safety: proportion of participants who experience any adverse event of interest (AE-I).
72 weeks
2B Primary efficacy: The within-participant change from baseline to week 72 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score, compared between active arm and placebo.
Key secondary efficacy: CFC2, a cognitive-functional composite

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
LX1001
1
3TC
2
ANAVEX2-73

Trial Design

4 Treatment Groups

600 mg
1 of 4
300 mg
1 of 4
150 mg
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

414 Total Participants · 4 Treatment Groups

Primary Treatment: PQ912 · Has Placebo Group · Phase 2

600 mg
Drug
Experimental Group · 1 Intervention: PQ912 · Intervention Types: Drug
300 mg
Drug
Experimental Group · 1 Intervention: PQ912 · Intervention Types: Drug
150 mg
Drug
Experimental Group · 1 Intervention: PQ912 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PQ912
2014
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks

Who is running the clinical trial?

Vivoryon Therapeutics N.V.Lead Sponsor
3 Previous Clinical Trials
397 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,417 Previous Clinical Trials
3,486,141 Total Patients Enrolled
Alzheimer's Disease Cooperative Study (ADCS)OTHER
23 Previous Clinical Trials
5,932 Total Patients Enrolled
Howard FeldmanPrincipal InvestigatorAlzheimer's Disease Cooperative Study (ADCS)
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 50 - 89 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Individuals aged 50 to 89 (inclusive) at screening were included in the study.
Having been diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or Mild probable AD based on the workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA).
indicates a high probability of cognitive impairment A mini-mental state examination score of 20-30 is indicative of a high likelihood of cognitive impairment.
The person has a low score on the Montreal Cognitive Assessment test.
The individual has some cognitive impairment, but it is not severe enough to be clinically diagnosed with dementia.
The study partner must be someone who interacts with the participant frequently (approximately >3-4 times per week), is willing to attend all clinic visits, and can help the participant follow study procedures.
predicts better clinical outcome in early MS The study found that a positive CSF AD biomarker signature was predictive of a better clinical outcome in early MS.
(AD) was found in 8% of participants who were clinically diagnosed with mild cognitive impairment (MCI) and in 24% of those with AD
References

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