Last reviewed · How we verify
A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine
Phase 2 trial testing Bryostatin in Alzheimer Disease in 108 participants. Completed in 25 July 2019.
| Lead sponsor | Neurotrope Bioscience, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 20 June 2018 |
| Primary completion | 25 July 2019 |
| Estimated completion | 25 July 2019 |
| Sites | 28 locations across United States |
Neurotrope Bioscience, Inc. — full company profile →
Adults 55 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 21 | |
| Placebo | 10 |
The Severe Impairment Battery (SIB) assesses cognition in subjects with moderate and severe Alzheimer's disease(AD). Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 1.3 | ± 8.42 |
| Placebo | 2.1 | ± 9.22 |
The Severe Impairment Battery (SIB) assesses cognition in subjects with Alzheimer's disease. SIB scores at Weeks 5, 9 and the Week 15 follow-up visit will be assessed. Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | -0.1 | ± 7.94 |
| Placebo | 0.7 | ± 11.0 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 2.7 | ± 7.18 |
| Placebo | 1.4 | ± 8.23 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 1.6 | ± 9.07 |
| Placebo | 2.1 | ± 9.66 |
The SIB is used to assess cognition in subjects with moderate and severe AD and is a useful outcome measure in advanced stages of disease. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | -3.1 | ± 9.55 |
| Placebo | 1.4 | ± 11.1 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 1.1 | ± 8.98 |
| Placebo | 1.1 | ± 13.3 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | -3.6 | ± 7.42 |
| Placebo | 1.9 | ± 15.3 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | -2.6 | ± 9.81 |
| Placebo | 0.3 | ± 16.5 |
Mini Mental State Exam version 2 (MMSE-2) scores between 10 and 15 are representative of moderately severe Alzheimer's disease. The SIB is used to assess cognition in subjects with moderate and severe AD and is a useful outcome measure in advanced stages of disease. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indi
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 1.4 | ± 6.57 |
| Placebo | 0.3 | ± 11.1 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 3.5 | ± 6.13 |
| Placebo | 1.5 | ± 4.61 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 3.9 | ± 7.80 |
| Placebo | 2.2 | ± 4.78 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 3.7 | ± 8.03 |
| Placebo | 2.8 | ± 4.74 |
Severe Impairment Battery (SIB) trend analyses will be assessed for individual patients. SIB scores were evaluated in subjects at various time points during the study. Individual-specific SIB slopes were estimated for all patients over each person's available SIB outcome measures.
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 29 | |
| Placebo | 29 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 23 | |
| Placebo | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Bryostatin 20µg | 0 | |
| Placebo | 2 |
Time frame: Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Bryostatin 20µg | Placebo |
|---|---|---|---|
| Right Distal Femur Fracture | Injury, poisoning and procedural complications | — | — |
| Well-diferentiated invasive colorectal adenocarcino | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| BRONCHITIS | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Diverticulitis | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Syncope | Nervous system disorders | — | — |
| Agitation | Psychiatric disorders | — | — |
| Suicidal ideation | Psychiatric disorders | — | — |
| Homicidal ideation | Psychiatric disorders | — | — |
| Renal failure | Renal and urinary disorders | — | — |
| Death | General disorders | — | — |
| Reaction | System | Bryostatin 20µg | Placebo |
|---|---|---|---|
| Agitation | Psychiatric disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Skin abrasion | Injury, poisoning and procedural complications | — | — |
Most-reported serious reactions: Right Distal Femur Fracture, Well-diferentiated invasive colorectal adenocarcino, BRONCHITIS, Urinary tract infection, Rectal haemorrhage, Diverticulitis, Fall, Syncope.
Data from ClinicalTrials.gov NCT03560245 adverse events section.
This is a randomized double-blind Placebo-controlled, Phase 2 study comparing bryostatin to placebo for the treatment of moderately severe to severe Alzheimer's disease in subjects not receiving memantine treatment. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug. Subjects will receive 7 doses of study drug during the study. The primary efficacy endpoint is defined as the change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score.
6 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03560245.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing