DementiaPhase 1/2NCT06946511
Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia
A Phase 1/2 study testing Peptide PMS-001 Intravenous Injection in people with Dementia, run by Ruijin Hospital at 2 sites in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to either the peptide intervention group (with dose escalation at 15mg, 30mg, 60mg, and 75mg) or the placebo control group. After learning and training, participants will receive an injection of PMS-001. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Dementia
- What is being tested?
- Peptide PMS-001 Intravenous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 31 Jan 2026
- Phase
- Phase 1/2
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be aged 60 to 80 years (inclusive) at the time of screening, regardless of gender.
- Participants must have a Clinical Dementia Rating (CDR) total score > 1, indicating moderate to severe dementia.
- Participants must provide written informed consent to participate in the study.
Who cannot join
- Presence of other neurological diseases that may cause cognitive decline, such as cerebrovascular disease, encephalitis, brain tumors, traumatic brain injury, epilepsy, Parkinson's disease, etc.
- Presence of metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folate and vitamin B12 deficiency, etc.
- Presence of severe psychiatric disorders, such as major depression.
- History of carbon monoxide poisoning.
- Presence of acute or severe life-threatening diseases.
- Presence of severe visual, auditory, or language impairments that would prevent the completion of neuropsychological assessments.
- Current use of psychotropic medications or a history of substance abuse.
- Individuals with specific allergy histories, or those with a history of allergies to two or more medications, foods (such as milk), or pollen (excluding untreated, asymptomatic seasonal allergies), or known allergies to components of the study drug or similar agents.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Chao Gao, MD，PhD, +86 18217590273, anshangaochao@163.com
Jun Liu, MD，PhD
About this study
This is a single-center, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to either the peptide intervention group (with dose escalation at 15mg, 30mg, 60mg, and 75mg) or the placebo control group. After learning and training, participants will receive an injection of PMS-001. The efficacy and safety of the intervention will be assessed at 1 hour, 1 day, 3 days, and 1 week post-intervention. This study aims to evaluate the effects of PMS-001 on improving long-delay recall in patients with moderate to severe dementia, as well as its safety profile.
- Conditions
- Dementia
- Being tested
- Peptide PMS-001 Intravenous Injection, Placebo
- Keywords
- Dementia, Treatment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide PMS-001 Intravenous InjectionDrug
Participants will receive intravenous injections of PMS-001.
PlaceboDrug
The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.
| Study group | Role | What they receive |
|---|---|---|
| PMS-001 Injection, 15mg | Experimental | Participants in this group will receive an injection of PMS-001 at a dose of 15mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the lowest dose level. Receives: Drug: Peptide PMS-001 Intravenous Injection |
| PMS-001 Injection, 30mg | Experimental | Participants in this group will receive an injection of PMS-001 at a dose of 30mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a moderate dose level. Receives: Drug: Peptide PMS-001 Intravenous Injection |
| PMS-001 Injection, 60mg | Experimental | Participants in this group will receive an injection of PMS-001 at a dose of 60mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a higher dose level. Receives: Drug: Peptide PMS-001 Intravenous Injection |
| PMS-001 Injection, 75mg | Experimental | Participants in this group will receive an injection of PMS-001 at a dose of 75mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the highest dose level. Receives: Drug: Peptide PMS-001 Intravenous Injection |
| Placebo | Placebo comparator | Participants in this group will receive an injection of placebo. This group serves as a control to compare the effects of PMS-001 on long-delay recall and safety in patients with moderate to severe dementia. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia.
The primary outcome will be specifically assessed using the sum of the long-delay recall scores from the following evaluation scales:
The Auditory Verbal Learning Test - Huashan Version (AVLT-H): The long-delay recall score (AVL-LR) is the number of words correctly recalled after a 20-minute delay. The AVL-LR score ranges from 0 to 12, with higher scores indicating better memory performance and lower scores suggesting more significant memory impairment.
Logical Memory Story A (LM-A) from the Wechsler Memory Scale - III (WMS-III): The long-delay recall score for LM-A measures the participant's ability to recall the story after a delay. The LM-A long-delay recall score ranges from 0 to 25, with higher scores indicating better memory function and lower scores pointing to memory deficits.
The changes in participants' total scores, which are the sum of the long-delay recall scores from both AVLT-H and WMS-III LM-A, before and after treatment will be evaluated using these scales.
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Secondary outcomes (5)
Assessment of the impact of Peptide PMS-001 on overall cognitive function in patients with moderate to severe dementia
Evaluation Scales: Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test that assesses multiple cognitive domains, including memory, attention, language, and visuospatial skills. The score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting worse cognitive outcomes.
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on executive function in patients with moderate to severe dementia.
Evaluation Scales: Trail Making Test B (TMT-B). The TMT-B is a widely used neuropsychological test that measures cognitive flexibility, attention, and processing speed. In this test, participants are required to connect a series of alternating numbers and letters as quickly as possible. The score is typically the time taken to complete the test, with a minimum possible score of 0 seconds (indicating no time taken, which is practically impossible) and no upper limit, as completion time can vary widely among individuals.
A lower TMT-B score (shorter completion time) indicates better performance, reflecting higher cognitive flexibility, better attention, and faster processing speed.
A higher TMT-B score (longer completion time) suggests more significant cognitive impairment, particularly in the areas of cognitive flexibility and attention.
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on language function in patients with moderate to severe dementia.
Evaluation Scales: Boston Naming Test (BNT). The BNT is a widely used neuropsychological test designed to assess language function, specifically the ability to name objects and concepts. It consists of a series of line drawings that participants are asked to name. The BNT typically includes 30 items, and the score ranges from 0 to 30, with each correctly named item contributing 1 point.
A higher BNT score (closer to 30) indicates better language function and naming ability, suggesting that the participant has less difficulty with word retrieval and object naming.
A lower BNT score (closer to 0) suggests more significant language impairment, which may be indicative of difficulties in word finding or naming, often seen in conditions such as aphasia or cognitive decline.
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on visuospatial function in patients with moderate to severe dementia.
Evaluation Scales: Clock Drawing Test (CDT). The CDT is a widely used neuropsychological test that assesses cognitive function, particularly executive function and visuospatial abilities. In this test, participants are asked to draw a clock, including all the numbers and setting the time to a specific hour (e.g., 10 past 11). The score ranges from 0 to 20, with higher scores indicating better cognitive function and visuospatial skills
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on event-related potentials in patients with moderate to severe dementia.
Evaluation Method: Event-Related Potentials (ERP). Event-Related Potentials (ERPs) are electrophysiological neural responses time-locked to specific stimuli and are widely used to assess various cognitive processes。 A larger amplitude generally indicates a stronger neural response to a stimulus. For example, in cognitive tasks, a larger P300 amplitude (a positive wave occurring around 300ms after a stimulus) is often associated with increased attention and cognitive processing。
Measured: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liu jun, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946511
- Sponsor's protocol ID
- RuijinH-2025125
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia
- ClinicalTrials.gov ID
- NCT06946511
- Acronym / sponsor ID
- RuijinH-2025125
- Conditions
- Dementia
- Keywords
- Dementia, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 27 Apr 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 is a single-center, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to either the peptide intervention group (with dose escalation at 15mg, 30mg, 60mg, and 75mg) or the placebo control group. After learning and training, participants will receive an injection of PMS-001. The efficacy and safety of the intervention will be assessed at 1 hour, 1 day, 3 days, and 1 week post-intervention. This study aims to evaluate the effects of PMS-001 on improving long-delay recall in patients with moderate to severe dementia, as well as its safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PMS-001 Injection, 15mg | Experimental | Drug: Peptide PMS-001 Intravenous InjectionParticipants in this group will receive an injection of PMS-001 at a dose of 15mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the lowest dose level. |
| PMS-001 Injection, 30mg | Experimental | Drug: Peptide PMS-001 Intravenous InjectionParticipants in this group will receive an injection of PMS-001 at a dose of 30mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a moderate dose level. |
| PMS-001 Injection, 60mg | Experimental | Drug: Peptide PMS-001 Intravenous InjectionParticipants in this group will receive an injection of PMS-001 at a dose of 60mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a higher dose level. |
| PMS-001 Injection, 75mg | Experimental | Drug: Peptide PMS-001 Intravenous InjectionParticipants in this group will receive an injection of PMS-001 at a dose of 75mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the highest dose level. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this group will receive an injection of placebo. This group serves as a control to compare the effects of PMS-001 on long-delay recall and safety in patients with moderate to severe dementia. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be aged 60 to 80 years (inclusive) at the time of screening, regardless of gender.
- Participants must have a Clinical Dementia Rating (CDR) total score > 1, indicating moderate to severe dementia.
- Participants must provide written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Presence of other neurological diseases that may cause cognitive decline, such as cerebrovascular disease, encephalitis, brain tumors, traumatic brain injury, epilepsy, Parkinson's disease, etc.
- Presence of metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folate and vitamin B12 deficiency, etc.
- Presence of severe psychiatric disorders, such as major depression.
- History of carbon monoxide poisoning.
- Presence of acute or severe life-threatening diseases.
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 |
|---|---|---|
| Peptide PMS-001 Intravenous InjectionParticipants will receive intravenous injections of PMS-001. | Drug | PMS-001 Injection, 15mg, PMS-001 Injection, 30mg, PMS-001 Injection, 60mg, PMS-001 Injection, 75mg |
| PlaceboThe control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001. | Drug | Placebo |
Primary outcome
To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia.
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
The primary outcome will be specifically assessed using the sum of the long-delay recall scores from the following evaluation scales: The Auditory Verbal Learning Test - Huashan Version (AVLT-H): The long-delay recall score (AVL-LR) is the number of words correctly recalled after a 20-minute delay. The AVL-LR score ranges from 0 to 12, with higher scores indicating better memory performance and lower scores suggesting more significant memory impairment. Logical Memory Story A (LM-A) from the Wechsler Memory Scale - III (WMS-III): The long-delay recall score for LM-A measures the participant's ability to recall the story after a delay. The LM-A long-delay recall score ranges from 0 to 25, with higher scores indicating better memory function and lower scores pointing to memory deficits. The changes in participants' total scores, which are the sum of the long-delay recall scores from both AVLT-H and WMS-III LM-A, before and after treatment will be evaluated using these scales.
5 secondary outcomes
Assessment of the impact of Peptide PMS-001 on overall cognitive function in patients with moderate to severe dementia
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on executive function in patients with moderate to severe dementia.
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on language function in patients with moderate to severe dementia.
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on visuospatial function in patients with moderate to severe dementia.
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
Assessment of the impact of Peptide PMS-001 on event-related potentials in patients with moderate to severe dementia.
Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peptide PMS-001 Intravenous Injection in people with Dementia, run by Ruijin Hospital at 2 sites in China.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Chao Gao, MD, PhD (+86 18217590273, anshangaochao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia. (time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.). 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 1 May 2025.