Evidence map›Paper›PMID 37996817›Full record

Trial reportBMC medicine2023

Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study.

Daizhuang Peng, Sumei Xu, Ting Zou, Yahui Wang, Wenjuan Ouyang, Yalan Zhang, Chengmei Dong, Dai Li, Jie Guo, Qiuying Shen and 4 more

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05787028 phase1completednot on this map

Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration

TypeinterventionalSponsorSouth China Center For Innovative PharmaceuticalsRan2019 to 2020Enrolled70ConditionsAlzheimer's DiseaseArmsAD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg, AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg
NCT05787041 phase1completednot on this map

The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects

TypeinterventionalSponsorSouth China Center For Innovative PharmaceuticalsRan2019 to 2019Enrolled16ConditionsAlzheimer DiseaseArmshigh-fat diet group（AD16 20mg）, fasted group（AD16 20mg）
NCT05806177 phase1completednot on this map

Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects

TypeinterventionalSponsorSouth China Center For Innovative PharmaceuticalsRan2020 to 2020Enrolled20ConditionsAlzheimer DiseaseArmsAD16 30mg、40mg, AD16 Placebo 30mg、40mg
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

Daizhuang PengNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Sumei XuNational Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410008, China.
Ting ZouNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Yahui WangThe South China Center for Innovative Pharmaceuticals, Guangzhou, China.
Wenjuan OuyangXiangya Changde Hospital, Central South University, Changde, China.
Yalan ZhangFirst People's Hospital of Chongqing Liangjiang New Area, Chongqing, China.
Chengmei DongNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Dai LiNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Jie GuoNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Qiuying ShenNational Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410008, China.
Xiaolei HuNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Wenzhi ZhouNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Xiaomin LiNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China.
Qun QinNational Institution of Drug Clinical Trial, Xiangya Hospital, Central South University, Changsha, 410008, China. 2395038683@qq.com.
Central South University · CNXiangya Hospital Central South University · CNChina International Science and Technology Cooperation · CNFirst People's Hospital of Chongqing · CNNational Clinical Research · USShanghai Innovative Research Center of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAD16 is a Class 1.1 new drug candidate for Alzheimer's disease (AD), which has demonstrated potential benefits in AD by reducing neuroinflammation in preclinical studies. Herein, the pharmacokinetics (PK), safety, and tolerability of single and multiple-dose AD16 and the effect of food were assessed in healthy Chinese adults.

methodsSingle-center, randomized, placebo-controlled, double-blind studies were conducted for single and multiple ascending doses. A total of 62 subjects were enrolled in single-dose groups; 10 each in 5, 10, 20, 30, and 40 mg groups, and 6 each in 60 and 80 mg dose groups. Twenty subjects were divided equally into 30 and 40 mg groups for the multiple-dose study. To determine the effect of a high-fat diet on AD16, 16 subjects were administered a single 20 mg dose of AD16 under the fasted and fed condition in a single-center, randomized, open-label, two-cycle, two-crossover study. Moreover, safety and PK parameters were also assessed.

resultsPlasma exposure to a single oral dose of AD16 increased at an approximate dose-increasing rate. The pharmacodynamic dose of the AD16 can be maintained through the accumulation effect of the drug within the safety window. Compared to fasting, ingesting a high-fat meal decelerated the rate of AD16 absorption, albeit without effect on its overall absorption. No dose-related toxicities were seen in any of the studies, all treatment-emergent adverse events were grade I/II, and no serious adverse event occurred.

conclusionsThe present study exhibited favorable safety, tolerability, and PK profile of AD16, supporting its further research as a potential drug treatment for AD.

trial registrationClinicalTrials.gov; NCT05787028, NCT05787041, NCT05806177. The SAD and FE studies were retrospectively registered on 28 March 2023. The MAD study was retrospectively registered on 10 April 2023.

Indexed as

Alzheimer DiseaseAdministration, OralAdultArea Under CurveCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFastingHumansNeuroinflammatory DiseasesAD16Alzheimer’s diseaseHigh-fat dietPharmacokineticsSafetyTolerability

Identifiers

PMID37996817
PMCPMC10666448
OpenAlexW4388943609

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.