NCT01072812

An Open-Label, Two-Stage Study to Evaluate the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Plasma and CSF After a 10-Day Treatment Period in Subjects With Amnestic Mild Cognitive Impairment

Terminated Phase 1 Last updated 20 April 2015

What this trial tests

Phase 1 trial testing Posiphen® tartrate capsules in Alzheimer's Disease in 5 participants. Terminated before completion.

Timeline

1 February 2010

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Annovis Bio Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 February 2010
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	1 location across United States

Drugs / interventions tested

• Posiphen® tartrate capsules — full drug profile →

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →
• Amnestic Mild Cognitive Impairment — all drugs for Amnestic Mild Cognitive Impairment →

Sponsor

Annovis Bio Inc. — full company profile →

Who can join

Adults 55 to 80, any sex, with Alzheimer's Disease or Amnestic Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pharmacokinetics
  Time frame: 10 days
  To determine the pharmacokinetics (PK) of Posiphen® and its metabolites in plasma and CSF after a 10-day treatment period with Posiphen®.
• Pharmacodynamics
  Time frame: 10 days
  To assess the effects of a 10-day treatment period with Posiphen® on the levels of amyloid precursor protein (APP), amyloid β protein 40 (Aβ40), amyloid β protein 42 (Aβ42), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE) in plasma and CSF from subjects with amnestic MCI.

Sponsor's own description

This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a 10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as primary pharmacodynamic (PD) objectives.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Posiphen as a candidate drug to lower CSF amyloid precursor protein, amyloid-β peptide and τ levels: target engagement, tolerability and pharmacokinetics in humans.
   Maccecchini ML, Chang MY, Pan C, John V, et al · · 2012 · cited 63× · PMID 22791904 · DOI 10.1136/jnnp-2012-302589
2. The Road Ahead to Cure Alzheimer's Disease: Development of Biological Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target Populations.
   Cavedo E, Lista S, Khachaturian Z, Aisen P, et al · · 2014 · cited 44× · PMID 26478889 · DOI 10.14283/jpad.2014.32
3. siRNA drug delivery across the blood-brain barrier in Alzheimer's disease.
   Imran Sajid M, Sultan Sheikh F, Anis F, Nasim N, et al · · 2023 · cited 26× · PMID 37353152 · DOI 10.1016/j.addr.2023.114968
4. APP dyshomeostasis in the pathogenesis of Alzheimer's disease: implications for current drug targets.
   Sirisi S, Sánchez-Aced É, Belbin O, Lleó A. · · 2024 · cited 18× · PMID 38951839 · DOI 10.1186/s13195-024-01504-w
5. Novel approaches to counter protein aggregation pathology in Parkinson's disease.
   Stott SRW, Wyse RK, Brundin P. · · 2020 · cited 7× · PMID 32247372 · DOI 10.1016/bs.pbr.2019.10.007
6. Comparative Analysis of Posiphen Pharmacokinetics across Different Species-Similar Absorption and Metabolism in Mouse, Rat, Dog and Human.
   Maccecchini ML, Mould DR. · · 2024 · cited 1× · PMID 38785991 · DOI 10.3390/biom14050582