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TerminatedPhase 1 / PHASE2Results posted

Study to Evaluate the Preliminary Safety, Efficacy, PK and PD of Bryostatin 1 in Patients With Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Preliminary Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bryostatin 1 in Patients With Alzheimer's Disease

Lead sponsor

Neurotrope Bioscience, Inc.

Asset

Bryostatin 1

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•prodromal AD

Primary endpoints

•Adverse Events as a Measure of Safety and Tolerability•Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment

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

NCT IDNCT02221947

Org study IDNTRP101-201

Timeline

Milestones

Study start2014-06 (month precision)

Study first posted2014-08-21estimated

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Results first posted2016-04-21estimated

Last update posted2017-11-06actual

Assets

Drug assets

Bryostatin 1

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age 50 - 85 yrs. Females are non-childbearing potential

•Patient must have a cognitive deficit present for at least 1 year and meet diagnostic criteria for probable Alzheimer's Disease Dementia by NIA-AA criteria or prodromal Alzheimer's Disease

•Mini Mental State Exam score of 16-26

•Ability to walk, at least with an assistive device

•Vision and hearing sufficient to comply with testing

•Normal cognitive and social functioning prior to onset of dementia, with evidence of progressive symptoms from patient or informant

•Consistent caregiver to accompany patient to visits

•Sufficient basic education to be able to complete the cognitive assessments

•Living outside an institution

Exclusion criteria

•Dementia due to any condition other than AD, including vascular dementia

•Significant neuroimaging abnormalities, previously known or discovered on screening MRI scan,

•Evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months

•Use of any drug within 14 days prior to randomization unless the dose of the drug and the condition being treated have been stable for at least 30 days and are expected to remain stable during the study

•Use of tobacco products or nicotine-containing products within 3 months before Day 1

•Use of high dose vitamin E, or valproic acid

•Any medical or psychiatric condition that may require medication or surgical treatment during the study

•Life expectancy less than 6 months

•Use of an investigational drug within 2 months prior to the screening visit

•Clinically significant neurological disease other than AD

•Major depression, alcohol or drug dependence or suicidality

•Psychotic episodes requiring hospitalization or antipsychotic therapy for more than 2 weeks within the past 10 years, not linked to AD

•Agitation sufficient to preclude participation in this trial

•Epilepsy or anti-epileptic drug therapy

•Abnormal laboratory tests that might point to another etiology for dementia;

•Acute or poorly controlled medical illness

•Likelihood, according to clinical judgment, of being transferred to a nursing home within 6 months

Endpoints (8)

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

Global cognition

Safety / tolerability / PK

Global cognition

4 endpoints

Primary/protocol endpoint

Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD

Time frame:48 hours post start of study drug infusion

change from baseline, improvement

Primary/registry result

Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD

Time frame:48 hours post start of study drug infusion

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale, change from baseline	Standard deviation
Bryostatin 1HVLT-R at 48hrs (change from baseline)n=6 Participants	1.3	2.16
RBANS figure recall at 48hrs (CBL)n=6 Participants	4.5	4.14
PlaceboHVLT-R at 48hrs (change from baseline)n=3 Participants	3.7	1.15
RBANS figure recall at 48hrs (CBL)n=3 Participants	6.7	3.06

Secondary/protocol endpoint

Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD

Time frame:Specified timepoints within 2 weeks post study drug infusion

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

change from baseline, improvement

Secondary/registry result

Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD

Time frame:Specified timepoints within 2 weeks post study drug infusion

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

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Bryostatin 1HVLT-R 24hr Delayed Recall (change from baseline)n=6 Participants	0.5	3.27
HVLT-R 2 Wks Delayed Recall (change from baseline)n=6 Participants	0.3	1.63
RBANS 24hr Figure Recall (change from baseline)n=6 Participants	4.7	4.76
RBANS 2 Wks Figure Recall (CBL)n=6 Participants	4.2	5.60
HVLT-R delayed recall of stimuli at 48hr (CBL)n=6 Participants	-1.2	1.17
Digit Symbol Coding baseline (observed)n=6 Participants	32.2	9.13
Digit Symbol Coding 24hrs post start of infusionn=6 Participants	36.0	10.75
Digit Symbol Coding 48hrs post start of infusionn=6 Participants	37.3	11.64
Digit Symbol Coding 2 wks post start of infusionn=6 Participants	38.3	7.61
CDR, CDR-SB baseline (observed)n=6 Participants	1.3	0.98
CDR, CDR-SB 2wks (observed)n=6 Participants	1.5	1.00
MMSE-2 3hrs post start of inf (change)n=6 Participants	1.8	1.72
Digit Symbol Coding baseline (observed)n=6 Participants	32.2	9.13
Digit Symbol Coding 3hrs post start of inf (observn=6 Participants	32.7	6.86
MMSE-2 at 72hrs (change from Baseline)n=6 Participants	2.6	1.52
MMSE-2 at 2wks (change from Baseline)n=6 Participants	3.3	1.86
PlaceboHVLT-R 24hr Delayed Recall (change from baseline)n=3 Participants	1.3	2.52
HVLT-R 2 Wks Delayed Recall (change from baseline)n=3 Participants	2.3	2.52
RBANS 24hr Figure Recall (change from baseline)n=3 Participants	6.0	2.65
RBANS 2 Wks Figure Recall (CBL)n=3 Participants	7.3	3.06
HVLT-R delayed recall of stimuli at 48hr (CBL)n=3 Participants	2.7	2.08
Digit Symbol Coding baseline (observed)n=3 Participants	42.3	12.50
Digit Symbol Coding 24hrs post start of infusionn=3 Participants	49.0	4.58
Digit Symbol Coding 48hrs post start of infusionn=3 Participants	53.7	4.73
Digit Symbol Coding 2 wks post start of infusionn=3 Participants	52.7	6.66
CDR, CDR-SB baseline (observed)n=3 Participants	0.7	0.29
CDR, CDR-SB 2wks (observed)n=3 Participants	0.7	0.29
MMSE-2 3hrs post start of inf (change)n=3 Participants	-1.0	2.65
Digit Symbol Coding baseline (observed)n=3 Participants	42.3	12.50
Digit Symbol Coding 3hrs post start of inf (observn=3 Participants	45.3	11.50
MMSE-2 at 72hrs (change from Baseline)n=3 Participants	3.3	2.52
MMSE-2 at 2wks (change from Baseline)n=3 Participants	4.7	1.15

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame:Within 2 weeks of study drug dosing

event count, event

Primary/registry result

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame:Within 2 weeks of study drug dosing

event count, event

Posted result

Group	Value (number), event	Reported bounds
Bryostatin 1Dizzinessn=6 Participants	0	-
Headachen=6 Participants	1	-
Rash Papularn=6 Participants	0	-
PlaceboDizzinessn=3 Participants	1	-
Headachen=3 Participants	1	-
Rash Papularn=3 Participants	1	-

Other/protocol endpoint

Pharmacokinetic Parameters of Bryostatin.

Time frame:Bryostatin plasma concentration pre-dose and at 15 min, 30 min, 1 hr, 1.5 hr, 2hr, 3hr and 6rs post dose.

concentration, descriptive

Other_pre_specified/registry result

Pharmacokinetic Parameters of Bryostatin.

Time frame:Bryostatin plasma concentration pre-dose and at 15 min, 30 min, 1 hr, 1.5 hr, 2hr, 3hr and 6rs post dose.

concentration, descriptive

Posted result

Group	Value (mean), bryostatin plasma concentration (ng/mL)	Standard deviation
Bryostatin 1predose Bryostatin Plasma Concentration (ng/mL)n=6 Participants	0.0	0.0
Concentration 15 min post (ng/mL)n=6 Participants	0.880	0.133
Concentration 30 min post (ng/mL)n=6 Participants	0.941	0.168
Concentration 1 hr post (ng/mL)n=6 Participants	1.04	0.309
Concentration 1.5 hrs post (ng/mL)n=6 Participants	0.181	0.148
Concentration 2 hrs post (ng/mL)n=6 Participants	0.0702	0.109
Concentration 3 hrs post (ng/mL)n=6 Participants	0.0	0.0
Concentration 6 hrs post (ng/mL)n=6 Participants	0.0	0.0
Cmax (ng/mL)n=6 Participants	1.09	0.246

mean Tmax(h)0.920

Bryostatin plasma concentration: mean Tmax (h)

mean (h*ng/mL)1.05

Bryostatin plasma concentration AUC0-last (h\*ng/mL)

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.